MAUDE Adverse Event Report: GALDERMA Q-MED SCULPTRA AESTHETIC; IMPLANT, DERMAL, FOR AESTHETIC USE

Lot Number A9141

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Facial Nerve Paralysis (1846)

Event Date 08/07/2019

Event Type  Injury  

Manufacturer Narrative

Pharmacovigilance comment: the serious events of facial paralysis and possible cerebrovascular accident were considered expected and possibly related to the treatment.Serious criteria include the need for medical interventions to prevent disability or permanent damage.The most likely etiology for the facial paralysis is injury to facial nerve.Potential contributory factors include injection technique.The very rare event of cerebrovascular accident has not been confirmed.The case meets the criteria for expedited reporting to the regulatory authorities.Follow-up information will be requested.Manufacturer narrative: the reported lot number was valid.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.

Event Description

Case reference number (b)(4), is a spontaneous report sent on (b)(6) 2019 by a physician which refers to a (b)(6) year-old caucasian female patient.The patient had no medical history or allergies.Concomitant treatments included diazepam [diazepam], unknown strength, daily and acetaminophen [acetaminophen] occasionally as needed.The patient had previously received treatment with unspecified filler and sculptra aesthetic on an unknown date.On (b)(6) 2019, the patient received treatment with 2 vials sculptra aesthetic (lot a9141) to temples, cheeks, periorbital area and jawline bilaterally with unknown needle and technique.Later the same day, on (b)(6) 2019, the patient experienced facial droop / some drooping of her left eye / left brow was much lower than her right (facial paralysis).It was reported that the patient noticed some drooping of her left eye in the evening on the same date of injection.On (b)(6) 2019, the patient had facial droop and was evaluated by the hcp on that date.The patient reported that 2.5 weeks later she noticed worsening of facial drooping on the left side, and this had become progressively worse since that time.On an unknown date, a few days prior, the patient visited her pcp who asked patient if she had a stroke due to facial drooping on her left side.Hence patient decided to contact the hcp about the ae.28 days later, upon evaluation on (b)(6) 2019, the hcp noted that the patient's left brow was much lower than her right.The patient's cheek and eye muscles on the left responded to stimuli, but facial droop was evident in those areas.Hcp reported if the patient had possible stroke / cva (cerebrovascular accident).The hcp reported that she was giving consideration to referring the patient to a neurologist.Treatment for the adverse event was not reported.Outcome at the time of the report: facial droop / some drooping of her left eye / left brow was much lower than her right was not recovered / not resolved.Possible stroke / cva was not recovered / not resolved.

Event Description

Case reference number (b)(4) is a spontaneous report sent on 04-sep-2019 by a physician which refers to a 60-year-old caucasian female patient with skin type fitzpatrick iii-iv.The patient medical history included skin cancer, frequent uti's and allergy to angora wool.Concomitant treatments included valium [diazepam], unknown strength, daily and otc tylenol [tylenol] occasionally as needed.The patient had previously received treatment with unspecified fillers and sculptra aesthetic on an unknown date.On (b)(6) 2019, the patient received treatment with dysport to glabella, philtrum, left eyebrow, perioral lines and mentalis.On (b)(6) 2019, the patient received treatment with 16 ml of sculptra aesthetic (lot a9141, exp.Date 31-dec-2021) to temples, cheeks, periorbital area and jawline bilaterally (8 ml on each side) with 26 gauge cannula (unknown injection technique).A total of 2ml of 2% lidocaine was added to the product before treatment.In (b)(6) 2019, two and a half weeks after the treatment (also reported as on (b)(6) 2019), the patient experienced facial droop/some drooping of her left eye/left brow was much lower than her right (facial paralysis).The severity of brow droop was moderate and facial droop was mild.On (b)(6) 2019, the patient was evaluated by the hcp, who noted the facial droop and that the patient's left brow was much lower than her right.The patient's cheek and eye muscles on the left responded to stimuli, but facial droop was evident in those areas.The patient told the hcp that in retrospect, the patient had noted some drooping of her left eye on the evening on the date of the injection.The patient reported that 2.5 weeks later she noticed worsening of facial drooping on the left side, and this had become progressively worse since that time.On an unknown date, a few days prior, the patient visited her pcp who asked patient if she had a stroke due to facial drooping on her left side.The patient did not present with any decreased muscle movement.Hence patient decided to contact the hcp about the ae.The hcp also wondered if the patient had a possible stroke/cva.On (b)(6) 2019, the treating office informed that the patient was fine and they did not believe the patient had a stroke.The medical director of the practice reviewed the case and the patient history, and found that the patient had received a dysport injection approximately one week prior to received the sculptra injection.The hcp reported that the facial drooping was related to the dysport injection and did not think the drooping was related to the treamtent with sculptra aesthetic.The patient had not been seen for follow up by neurology.The hcp previously considered referring the patient to neurology but declined to do so when it was established that the patient had received dysport one week prior to the sculptra aesthetic.On (b)(6) 2019, the patient was scheduled to be reviewed at the clinic by the hcp.The patient has not received any treatment to this point for the event.On (b)(6) 2019, the patient received corrective treatment with 9 units of dysport to left brow.Improvement in the left brow was visible.At the time of report, the patient recovered from facial droop and was recovering from eyebrow droop.The medical director at the practice assessed the case as non-serious.Outcome at the time of the report: facial droop/some drooping of her left eye/left brow was much lower than her right was recovering/resolving.Tracking list: v.0 initial; v.1 fu received on 02-oct-2019 from a health care professional (office manager).Additional information was received from the medical director (physician) at the treating office on 08-oct-2019.Patient demographic details, medical history, treatment date of dysport, device location, volume used and cannula type were added.The outcome of event was resolving.The hcp confirmed that the patient did not experience stroke and believed the event of facial drooping was related to the dysport treatment.The case was downgraded to non-serious based on the follow-up information.

Manufacturer Narrative

Pharmacovigilance comment: the non-serious event of facial paralysis was considered expected and a causal relationship to the treatment cannot be ruled out.The most likely etiology for the facial paralysis is local spread of the recent dysport treatment; however, injury to the facial nerve during the sculptra treatment procedure could potentially contribute to the event.Potential contributory factors include prior treatment with botulinum toxin and injection technique.Based on the follow-up information received, the case was downgraded to non-serious status.The case no longer meets the seriousness criteria for expedited reporting to the regulatory authorities.Manufacturer narrative: sanofi confirms that no quality issues have been identified in the overall manufacturing process of the specified batch, which resulted to be conformed to the cgmp and to the specifications requirements.Capa comment: the information in this single case does not suggest involvement of a nonconforming product or quality problem and will not initiate a corrective or preventive action.

• Brand Name: SCULPTRA AESTHETIC
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): GALDERMA Q-MED; seminariegatan 21; uppsala, SE-75 2 28; SW SE-752 28
• MDR Report Key: 9071721
• MDR Text Key: 163010725
• Report Number: 1000118068-2019-00009
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Lot Number: A9141
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/24/2019
• Distributor Facility Aware Date: 10/02/2019
• Event Location: Other
• Date Report to Manufacturer: 10/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2% LIDOCAINE.; ACETAMINOPHEN.; ACETAMINOPHEN.; DIAZEPAM.; DIAZEPAM.; DYSPORT.
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR