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| Lot Number 17674 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Ischemia (1942); Nausea (1970); Necrosis (1971); Optical Nerve Damage (1986); Loss of Vision (2139); Eye Pain (4467); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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| Event Date 07/12/2021 |
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Event Type
Injury
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Manufacturer Narrative
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Company comment: the serious expected events of sudden visual loss, optic nerve infarction and blindness unilateral were considered possibly related to the treatment.Serious criteria included the need for hospitalization and permanent damage.The non-serious, expected event of nausea, eye pain and the unexpected events of circulatory instability and hyperhidrosis were considered possibly related to the treatment.The potential root cause includes intravascular filler injection leading to vascular compromise.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.The information in this case does not indicate a nonconforming product or malfunction.The performed investigations are therefore considered adequate and no additional investigations will be conducted.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 12-jul-2021 by an other health professional concerning a (b)(6) female patient.Additional information was received on 13-jul-2021 and 16-jul-2021 from the same reporter.The patient's medical history included deep glabellar folds, pigment disorders, herpes and an allergy to nickel.The patient did not take any medication in the last weeks prior to the injection.The patient had not received any treatment with fillers in the past and had no dermatologic treatments nor operations in facial area in the past.The patient was not suffering from following diseases: porphyria, diseases of the cardiovascular system, frequent nose bleeds, bruises, blood coagulation disorders, wound healing disorders, infection diseases, autoimmune diseases, epilepsy and impaired liver and kidney function.On (b)(6) 2021, at 6:00 pm, the patient received treatment with restylane lidocaine (lot 17674) with an unknown injection technique.After disinfection, an injection channel was laid with a 23 g / 60 mm cannula, and 0.5 ml of restylane lidocaine was injected with a blunt cannula to the right site of the patient's glabella.According to the reporter, everything was fine.Then an injection channel was laid on the left site with a blunt 25g pix'l cannula, and 0.3 ml of restylane lidocaine was injected to the left site of the patient's glabella.Same day of injection, on (b)(6) 2021, after looking into the mirror, the patient was satisfied at first.Suddenly the patient experienced pain in left eye (eye pain) and could not longer see anything/severe visual disorders(sudden visual loss).The patient also experienced nausea (nausea), severe sweating (hyperhidrosis) and had circulatory problems(cardiovascular disorder).On (b)(6) 2021, the patient received a hard massage and cooling as corrective treatment, but without success.An ambulance was called and the patient got hospitalized.A hyalase (hyaluronidase) treatment was recommended but was not received.On the morning of (b)(6) 2021, the patient contacted the alternative practitioner, who had performed the treatment, and told her that she experienced an ocular infarction(optic nerve infarction).On (b)(6) 2021, the reporter sent pictures before and after the treatment and informed that the patient was completely blind in the left eye(blindness unilateral).The reporter assessed causality between the treatment and the adverse events as possible.Outcome at the time of the report: pain in left eye was not recovered/not resolved/ongoing.Could not longer see anything/severe visual disorders was not recovered/not resolved/ongoing.Nausea was not recovered/not resolved/ongoing.Sweating was not recovered/not resolved/ongoing.Circulatory problems was not recovered/not resolved/ongoing.Ocular infarction was not recovered/not resolved/ongoing.Completely blind in the left eye was not recovered/not resolved/ongoing.
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Manufacturer Narrative
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Company comment: the serious expected events of sudden visual loss, optic nerve infarction, blindness unilateral and necrosis at implant site were considered possibly related to the treatment.Serious criteria included the need for multiple medical interventions, hospitalization and permanent damage.The non-serious, expected event of nausea, eye pain and the unexpected events of cardiovascular disorder and hyperhidrosis were considered possibly related to the treatment.The potential root cause includes intravascular filler injection leading to vascular compromise.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and indicate a possible involvement of the product.The reported lot number was valid and verified the reported product.A batch record review has also been performed and no potential quality issues have been identified in the manufacturing process of the specified batch.The batch was manufactured and released according to galderma uppsala quality management system.Thus, it is not assessed as likely that the reaction was caused by a non-conforming product and nothing in the report suggests a product quality issue or a counterfeit product.The potential root cause includes intra vascular filler injection leading to vascular compromise.The performed investigations are therefore considered adequate and no additional investigations will be conducted.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 12-jul-2021 by an other health professional concerning a 43-year-old female patient.Additional information was received on 13-jul-2021 and 16-jul-2021 from the same reporter.The patient's medical history included deep glabellar folds, pigment disorders, herpes and an allergy to nickel.The patient did not take any medication in the last weeks prior to the injection.The patient had not received any treatment with fillers in the past and had no dermatologic treatments nor operations in facial area in the past.The patient was not suffering from following diseases: porphyria, diseases of the cardiovascular system, frequent nose bleeds, bruises, blood coagulation disorders, wound healing disorders, infection diseases, autoimmune diseases, epilepsy and impaired liver and kidney function.On (b)(6) 2021, at 6:00 pm, the patient received treatment with restylane lidocaine (lot 17674) with an unknown injection technique.After disinfection, an injection channel was laid with a 23 g/60 mm cannula, and 0.5 ml of restylane lidocaine was injected with a blunt cannula to the right site of the patient's glabella.According to the reporter, everything was fine.Then an injection channel was laid on the left site with a blunt 25g pix'l cannula, and 0.3 ml of restylane lidocaine was injected to the left site of the patient's glabella.Same day of injection, on (b)(6) 2021, after looking into the mirror, the patient was satisfied at first.Suddenly the patient experienced pain in left eye (eye pain) and could not longer see anything/severe visual disorders(sudden visual loss).The patient also experienced nausea (nausea), severe sweating (hyperhidrosis) and had circulatory problems(cardiovascular disorder).On (b)(6) 2021, the patient received a hard massage and cooling as corrective treatment, but without success.An ambulance was called and the patient got hospitalized.A hyalase treatment was recommended but was not received.On (b)(6) 2021, the patient also received treatment with morphine [morphine] against her pain, the patient was completely blind in the left eye(blindness unilateral) now, and investigations were ongoing.On the morning of (b)(6) 2021, the patient contacted the alternative practitioner, who had performed the treatment, and told her that she experienced an ocular infarction(optic nerve infarction).On (b)(6) 2021, the patient stated that she felt a little better, but she would stay for a while in the hospital due to the blindness in her left eye.She did not specify about further damages.On (b)(6) 2021, the reporter sent pictures before and after the treatment and informed that the patient was completely blind in the left eye.The patient was still in the hospital.The patient had not received hyaluronidase in hospital, received only aspirin [aspirin], an unspecified corticoid [corticosteroid nos].The reporter assessed causality between the treatment and the adverse events as possible.As per follow up information received on 03-aug-2021, the patient was still blind on the left eye and she experienced also necrotic skin tissue (implant site necrosis) close to her eye.In the course of her hospitalization, the patient was treated with an unspecified corticoid.An application of hyaluronidase was not considered by the treating physicians.The treatment had not yet been completed.According to the patient the aim was to preserve the eye.Last information received in an e-mail on 13-aug-2021 from the reporter, stated that no further information had been able to be received and that the contact with the patient was terminated.Outcome at the time of the report: could not longer see anything/severe visual disorders was not recovered/not resolved/ongoing.Completely blind in the left eye was not recovered/not resolved/ongoing.Ocular infarction was not recovered/not resolved/ongoing.Necrotic skin tissue was unknown.Nausea was recovering/resolving.Sweating was recovering/resolving.Circulatory problems was recovering/resolving.Pain in left eye was recovering/resolving.Tracking list: v.0 initial.V.1 fu received on 28-jul-2021 from the same reporter.Hospitalization status, outcome of events and corrective treatment details were updated.V.2 fu received on 03-aug-2021 from the patient.Event (necrotic skin tissue) was added.13-aug 2021.Additional information received stating that no additional information has been able to be obtained.
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Manufacturer Narrative
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Company comment: the serious events of sudden visual loss, optic nerve infarction, blindness unilateral, necrosis at implant site, ophthalmic artery occlusion, ophthalmoplegia, optic ischaemic neuropathy, anterior segment ischaemia and retinal ischaemia were considered expected and possibly related to the treatment.Seriousness criteria include the need for multiple medical interventions, hospitalization and permanent damage.The non-serious, expected events of nausea, eye pain, implant site erythema, implant site swelling and implant site haemorrhage, cutaneous contour deformity, eyelid ptosis, enophthalmos, strabismus, papilloedema, corneal oedema, conjunctival oedema, retinal oedema and choroidal effusion, and the unexpected events of cardiovascular disorder, hyperhidrosis, lagophthalmos, madarosis, hypotony of eye, corneal erosion, pupillary reflex impaired, conjunctival hyperaemia, iris atrophy, atrophy of globe, retinal degeneration and vitreous detachment were considered possibly related to the treatment.Iris atrophy, atrophy of globe, retinal degeneration and vitreous detachment were considered to be secondary events of the ophthalmic artery occlusion.The potential root cause includes intravascular filler injection leading to vascular occlusion and its manifestations.Potential contributory factors include injection technique and treatment performed by a non-medical practitioner.The case meets the criteria for expedited reporting to the regulatory authorities.Product note: routine investigations have been performed and provide sufficient information to assess the potential root cause and indicate a possible association to the treatment procedure.The reported lot number was valid and verified the reported product.A batch record review has also been performed and no potential quality issues have been identified in the manufacturing process of the specified batch.The batch was manufactured and released according to galderma uppsala quality management system.Thus, it is not assessed as likely that the reaction was caused by a non-conforming product and nothing in the report suggests a product quality issue or a counterfeit product.The potential root cause includes intravascular filler injection leading to vascular compromise.The performed investigations are therefore considered adequate and no additional investigations will be conducted.Capa comment: no corrective or preventive actions are deemed necessary based on the outcome of the performed investigations.G7 adverse events (continued): madarosis; hypotony of eye; implant site swelling; eyelid ptosis; implant site erythema; corneal oedema; corneal erosion; pupillary reflex impaired; implant site haemorrhage; conjunctival hyperaemia; conjunctival oedema; papilloedema; retinal oedema; retinal degeneration; vitreous detachment; cutaneous contour deformity; enophthalmos; choroidal effusion; iris atrophy; atrophy of globe.
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Event Description
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Case reference number (b)(4) is a spontaneous report sent on 12-jul-2021 by an health professional concerning a 43-year-old caucasian female patient.Additional information was received on 13-jul-2021 and 16-jul-2021 from the same reporter.The patient's medical history included deep glabellar folds, pigment disorders, herpes and an allergy to nickel.The patient did not take any medication in the last weeks prior to the injection.The patient had not received any treatment with fillers in the past and had no dermatologic treatments nor operations in facial area in the past.The patient was not suffering from following diseases: porphyria, diseases of the cardiovascular system, frequent nose bleeds, bruises, blood coagulation disorders, wound healing disorders, infection diseases, autoimmune diseases, epilepsy and impaired liver and kidney function.On (b)(6) 2021, at 6:00 pm, the patient received treatment with restylane lidocaine (lot 17674) with an unknown injection technique.After disinfection, an injection channel was laid with a 23 g/60 mm cannula, and 0.5 ml of restylane lidocaine was injected with a blunt cannula to the right site of the patient's glabella.According to the reporter, everything was fine.Then an injection channel was laid on the left site with a blunt 25g pix'l cannula, and 0.3 ml of restylane lidocaine was injected to the left site of the patient's glabella.Same day of injection, on (b)(6) 2021, after looking into the mirror, the patient was satisfied at first.Suddenly, the patient experienced pain in left eye (eye pain) and could not longer see anything/severe visual disorders(sudden visual loss).The patient also experienced nausea (nausea), severe sweating (hyperhidrosis) and had circulatory problems(cardiovascular disorder).On (b)(6) 2021, the patient received a hard massage and cooling as corrective treatment, but without success.An ambulance was called and the patient got hospitalized.A hyalase treatment was recommended but was not received.On (b)(6) 2021, the patient also received treatment with morphine [morphine] against her pain, the patient was completely blind in the left eye(blindness unilateral) now, and investigations were ongoing.On the morning of (b)(6) 2021, the patient contacted the alternative practitioner, who had performed the treatment, and told her that she experienced an ocular infarction (optic nerve infarction).On (b)(6) 2021, the patient stated that she felt a little better, but she would stay for a while in the hospital due to the blindness in her left eye.She did not specify about further damages.On (b)(6) 2021, the reporter sent pictures before and after the treatment and informed that the patient was completely blind in the left eye.The patient was still in the hospital.The patient had not received hyaluronidase in hospital, received only aspirin [aspirin], an unspecified corticoid [corticosteroid nos].The reporter assessed causality between the treatment and the adverse events as possible.As per follow up information received on (b)(6) 2021, the patient was still blind on the left eye and she experienced also necrotic skin tissue/necrotic changes (implant site necrosis) close to her eye.In the course of her hospitalization, the patient was treated with an unspecified corticoid.An application of hyaluronidase was not considered by the treating physicians.The treatment had not yet been completed.According to the patient the aim was to preserve the eye.Last information received in an e-mail on 13-aug-2021 from the reporter, stated that no further information had been able to be received and that the contact with the patient was terminated.On 25-apr-2022, additional follow up information was received in the form of a literature article and reported in case (b)(4).Literature article title: davidova p, muller m, wenner y, konig c, kenikstul n, kohnen t.Ophthalmic artery occlusion after glabellar hyaluronic acid filler injection.American journal of ophthalmology case reports 2022;26:101407.Abstract: a healthy, 43-year-old woman underwent her first hyaluronic acid injection in the glabella and went blind on her left eye immediately thereafter.The massaging of the injection area and observation were performed, before she presented with swelling of the left forehead and upper lid, ptosis, complete ophthalmoplegia and blindness in our hospital.Immediate massaging of the globe and systemic therapy including acetylsalicylic acid, tinzaparin sodium and cortisone was initiated and hyaluronidase injections in the injection area were performed.In the further course, the patient developed necrotic and hemorrhagic skin and mucosal lesions, lagophthalmos, anterior and posterior segment ischemia and globe hypotonia with consecutive globe deformation.In the follow-up of 2.5 months, lid swelling, lagophthalmos and ptosis resolved and keratopathy improved but blindness, skin lesions and strabismus with reduced eye motility were still present and madarosis and early enophthalmos were detected.This case report illustrates fatal complications, their course, pathomechanism, management and outcome after hyaluronic acid filler injection in the glabella in a healthy woman.Case report: a 43-year-old caucasian female healthy patient underwent glabellar injection of 0.7 ml hyaluronic acid/ lidocaine (restylane) by a nonmedical practitioner.It was the patient's first filler injection, her former visual acuity was 20/20 on both eyes and no other diseases, including of the eyes, were present before the procedure.According to the patient, the visual field of her left eye already darkened during the procedure and massaging of the injection area with observation was performed, before she presented to our hospital 1 h later.One hour after the hyaluronic acid injection, the patient was treated with acetylsalicylic acid 100 mg (s.I.D, per oral), tinzaparin sodium 4.500 ie (s.I.D, subcutaneous), methylprednisolone 100 mg (s.I.D, intravenous for three days), then prednisone 90 mg per oral, pantoprazole 40 mg (s.I.D, per os, during steroid medication).Swelling of the left forehead and upper lid, ptosis and complete ophthalmoplegia were detectable.The left eye had no light perception, the intraocular pressure was normal, the left pupil barely reacted to light and showed a relative afferent pupillary defect.The anterior segment did not show further pathological findings.In the fundoscopy, the optic disc presented with sharp margins, the arteries were thinned, cherry red spot and retinal whitening were documented.Immediate massaging of the globe was attempted and further neurological diagnostic, including nuclear magnetic resonance imaging, was performed.Besides the ophthalmic pathologies, the neurological clinical findings were normal and in the medical imaging an ischemic optic neuropathy was suspected.Therapy with acetylsalicylic acid, tinzaparin sodium, methylprednisolone, pantoprazole, pain management and antiseptic compresses for the forehead was initiated.The dermatologists performed three hyaluronidase injections in the injection area.Two days after the glabellar hyaluronic acid injection, the periocular complications were still manifest with hemorrhagic changes on the upper lid.There was swelling, redness and surface irregularities on the left side of the forehead, nose and left upper lid and distinct ptosis.The left eye was slightly depressed while the right eye was slightly elevated indicating opthalmoplegia.Two days after the hyaluronic acid injection, dexpanthenol 5% eye ointment (q.I.D.) and ofloxacin 3mg/g eye ointment (q.I.D) were added to the patient's corrective therapy.The patient also developed skin lesions on the nose bridge, anterior segment ischemia and globe hypotonia.The conjunctiva was injected, the cornea had erosion, edema and descemet folds, the pupil was average sized, ovally warped, showing no light reaction.A perforation was ruled out.In the next two days, the skin on the forehead and the inner third of the upper lid showed early necrotic changes, the vertical lid fissure width was 9 mm, levator function 5 mm and a lagophthalmos of 3 mm was visible.Exophthalmometry was symmetrical and eye movement could be achieved approximately 5 degree downwards.The conjunctiva showed chemosis, keratopathy worsened and anterior chamber flattened to mid depth.A sonography revealed globe deformation and swelling of the choroidea.Due to the strong suspicion of an ophthalmic artery occlusion the otolaryngologists were involved in this case and found necrotic mucosal tissue at the top of the left middle nasal concha.The cranial nuclear magnetic resonance imaging was repeated, revealing a collapsed globe and edematous left optic nerve with diffusion restriction.In the angiography, an ophthalmic artery occlusion could not be confirmed or ruled out with certainty.Four days after the hyaluronic acid injection, the patient received an increased dose of dexpanthenol 5% eye ointment every 2 hour, and moisture chamber (during lagophthalmos), clindamycin 300 mg (q.I.D, per os, prescribed by dermatologists), nasal spray containing sea water and dexpanthenol were added to the patient's corrective therapy.The following 4 days (day 6 after hyaluronic acid injection), prednisolone 10 mg/ml eye drops (t.I.D) and atropine 0.5% eye drops (b.I.D) were added and prednisone was reduced to 60 mg (s.I.D, per os).Ten days after the injection complete lid closure could be achieved, depression, elevation and abduction improved slightly, corneal erosion decreased, no iridal ischemic signs were detected, the lens had little lentodonesis and the sonographic findings were constant.Two and a half weeks after the hyaluronic acid injection, lid swelling and ptosis resolved completely, showing a symmetrical lid fissure width of 10 mm and normal levator function.Amaurosis and severe globe hypotonia were still manifest.The conjunctiva was sparsely injected, the cornea was clear, stippled, without corneal erosion.Compared to the former medical findings, the anterior chamber deepened.The optic nerve was pale with indistinct margins, the retinal arteries were very thin and the retina was ischemic and edematous.No cherry red spot was visible and, in the sonography, the globe was still deformed.At day ten, the patient's corrective treatment with dexpanthenol 5% eye ointment was reduced to 6 times daily, prednisolone 10 mg/ml eye drops reduced (b.I.D), atropine 0.5% eye drops reduced (s.I.D) and prednisone reduced to 50 mg (s.I.D, per os).The prednisone dose was further reduced of 10 mg every three days, remaining on 10 mg) and clindamycin 300 mg was discontinued.Two and a half week after the injection, the patient's ofloxacin 3mg/g eye ointment usage was reduced (t.I.D) and tinzaparin sodium 4.500 ie was discontinued.A further control examination after 6 weeks revealed redness and surface irregularity on the forehead and madarosis on the inner third of the upper lid.Abduction of 25 degree, complete elevation, depression of 15 degree and terminally restricted adduction with strabismus showing esotropia and hypertropia was visible.In the exophthalmometry a 2 mm more posterior location of the affected eye was detected.The visual acuity kept unchanged, the globe started to build up intraocular pressure, the anterior chamber further deepened, mild hyperemia of the iris was detectable, the pupil was still warped, developing posterior synechiae in the inferior nasal quadrant.The fundoscopy showed partially a slightly increased retinal vein caliber with tortuosity and very poor to no retinal artery filling with ischemic retinal areas.The oct revealed internal and external retinal atrophy with loss of retinal architecture.Six weeks after the hyaluronic acid injection, the prednisone dose was reduced to 5 mg (s.I.D, per os, for two weeks, then discontinued) and prednisolone 10 mg/ml eye drops frequency reduced (s.I.D).The patient discontinued the use of atropine 0.5% eye drops and ofloxacin 3 mg/ ml eye ointment.Two and a half month after the incident the clinical findings remained constant.Fundus of the left eye showed the optic nerve was pale with indistinct margins, very poor to no retinal artery filling, partially slightly increased retinal vein caliber, no cherry red spot and ischemic areas were detectable.At that point, the acetylsalicylic acid 100 mg was discontinued and prednisolone 10 mg/ml eye drops replaced with dexamethasone 1 mg/ml eye drops (s.I.D, without preservatives).Discussion: in our case, the injection of 0.7 ml of hyaluronic acid into the supratrochlear artery resulted in occlusion of the ophthalmic artery and its branches.The skin lesions were still present after 2.5 months.It was stated that ocular movement was weakened in every direction, which is in accordance with our patient's findings.In our patient normal levator function, completely recovered ptosis and better, but still reduced, eye movement and strabismus were present after 2.5 months.Further reported complications of ophthalmic artery occlusion were anterior segment ischemia, as was found in our patient, iris atrophy and phthisis bulbi on the long term.After 2.5 months, irregular widened pupil without iris atrophy or iris ischemia but mild hyperemia of the iris were obvious in our case.We found an early enophthalmos of the affected eye, which was also reported from another group after 6 months of follow-up.A phthisis bulbi or even enucleation in the further course cannot be excluded.Further known complications like brain infarcts or hemorrhage were ruled out in our patient.In our case, the immediate therapy consisted of acetylsalicylic acid, tinzaparin sodium, corticosteroids and observation.Regarding the lack of thrombotic cause of the occlusion, no intra-arterial thrombolysis was recommended.Due to extensive ischemic retinal and neuropathic changes already at time of presentation, the lack of benefit according to literature and to minimize further, possible complications, no hyaluronidase injections, except on the forehead, were performed since visual rehabilitation was not to be expected.In the angiography an ophthalmic artery occlusion could not be ascertained or ruled out.But the subsequent complications can be attributed to the branches of the ophthalmic artery, bearing in mind interindividual differences and anastomoses, and were also described in other studies as mentioned above.Further findings like the missing cherry rot spot due to retinal and choroidal insufficiency, extensive, whiteish, edematous retinal ischemia, poor or no retinal artery filling and disc edema are seen in ophthalmic artery occlusion.Due to the restricted treatment possibilities and very poor outcome the further course remains to be seen.Conclusion: the outcome of ophthalmic artery occlusion following glabellar hyaluronic acid filler injection is very poor.It was essential that the practitioner has sufficient knowledge about facial anatomy, the implementation of this procedure and management of complications.The practitioner should be aware of potential devastating consequences and inform the patient specifically about this rare complication, since they might be irreversible and far-reaching.On 28-jul-2022, during preparation of local signal detection, local affiliate found serious case (b)(4) from international literature to be identical with our previously reported serious case (b)(4).The treating physicians published the case in international literature afterwards.The affiliate could identify the patient with the help of un-pseudonymized photographies in the local files and in the publication.All the information from case de2022004607 has been included into case (b)(4).Tracking list: v.0 initial v.1 fu received on 28-jul-2021 from the same reporter: hospitalization status, outcome of events and corrective treatment details were updated.V.2 fu received on (b)(6) 2021 from the patient: event (necrotic skin tissue) was added.On 13-aug 2021, additional information received stating that no additional information has been able to be obtained.V.3 fu received on 25-apr-2022: during preparation of local signal detection, local affiliate identified serious case (b)(4) from international literature to be identical with our previously reported serious case (b)(4).All information from the literature article has been included into this case (b)(4).
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