| Model Number 100-300 MICROM |
| Device Problem
Insufficient Information (3190)
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| Patient Problems
Unspecified Infection (1930); Necrosis (1971); Test Result (2695)
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| Event Date 04/10/2015 |
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Event Type
Injury
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Event Description
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Necrotizing cholangitis (cholangitis].Case description: initial information received on (b)(6)2015: this spontaneous case report was received from a physician via company distributor and it concerned a (b)(6) female patient affected by multiple hepatocellular carcinoma (hcc).Patient's past medical history included: nephrosis and spinal stenosis.Patient's concomitant drug was gelpart (porous gelatine particles, 1mm).On (b)(6) 2015, the patient underwent transcatheter arterial chemoembolization (tace) using drug-eluting dc bead (100-300 microm) loaded with 60 mg of epirubicin hydrochloride.Dc bead loaded with epirubicin (0.35 vial) was injected into multiple hepatocellular carcinoma (hcc) through the right inferior phrenic artery.Dc bead loaded with epirubicin and gelpart was injected through distal of a5 (0.2 vial) and through cholecystic artery (0.05 vial).On (b)(6) 2015 patient laboratory data were:total bilirubin 0.7mg/dl (normal range: 0.2-1.0mg/dl), direct bilirubin 0.1mg/dl (normal range: 0.0-0.2 mg/dl), ast 27 iu/l (normal range: 10-35 iu/l), alt 22iu/l (normal range: 5-40), ldh 274 iu/l (normal range: 120-240iu/l), al-p 209iu/l (normal range 115-359iu/l), gamma-gt 54 iu/l (normal range: <30 iu/l), ck 95 iu/l (normal range 44-170 iu/l), wbc 6.10 10 3/microl (normal range: 4.00-9.00), and crp 0.22 mg/dl (normal range: <0.30).On (b)(6) 2015, total bilirubin was 1.2 mg/dl, direct bilirubin was 0.2 mg/dl, ast was 505 iu/l, alt was 359 iu/l, ldh was 1376 iu/l, al-p 317 iu/l, gamma-gt was 65 iu/l, wbc was 14.70 10 31microl and crp was 2.02 mg/dl.On (b)(6) 2015, the patient presented necrotizing cholangitis diagnosed on ct-scan, which required hospitalisation.Patient's laboratory data on (b)(6) 2015 were: total bilirubin 1.6 mg/dl, direct bilirubin 0.4 mg/dl, ast 403 iu/l, alt 370 iu/l, ldh 1034 iu/l, gamma-gt 71 iu/l, al-p 316 iu/l, ck 690 iu/l, wbc 10.7 10a31microl, and crp 6.06 mg/dl.Since the patient presented a phlebothrombosis of lower extremities and right pulmonary venous thrombus, percutaneous drainage under ct scan was performed, without cholecystectomy.Meropenem 3g per day was also given.No progression to peritonitis was noted.On (b)(6) 2015, necrotizing cholangitis was improving under treatment.The patient was in relatively stable condition.Decannulation was scheduled.Patient's laboratory data on (b)(6) 2015 were: total bilirubin: 1.0 mg/dl, direct bilirubin: 0.2 mg/dl, ast: 16 iu/l, alt: 15 iu/l, ldh: 220 iu/l, gamma-gt: 98 iu/l, wbc 12.90 10 31microl and crp 4.47 mg/dl.(other laboratory data reported in the laboratory data section).The physician assessed the necrotizing cholangitis as probably related to the embolization of cholecystic artery, and the phlebothrombosis of lower extremities and right pulmonary v venous thrombus as not related to dcbead.Case comment: necrotizing cholangitis, phlebothrombosis of lower extremities and right pulmonary venous thrombus are considered unlisted according to dc bead current instruction for use.The physician considered only the event necrotizing cholangitis as related to the use of dc bead.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis.
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Manufacturer Narrative
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Dc bead with epirubicin hydrochloride was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The use of dc bead with epirubicin hydrochloride is considered off-label use.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
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Event Description
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Phlebothrombosis of lower extremities (venous thrombosis).Right pulmonary venous thrombus.F/u info received on 06/23/2015: info on sales data for dc bead was provided and added in case comment.Case comment: the first sales for dc bead in (b)(6) were in 2004.Sales data from january 2010 for dc bead is: (b)(4).The follow-up info received on 06/23/2015 did not change the case assessment.
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Manufacturer Narrative
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Dc bead with epirubicin hydrochloride was reported to have been used in the treatment of this patient the equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The use of dc bead with epirubicin hydrochloride is considered off-label use.The device has not been sent to the manufacturer for evaluation no batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
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Event Description
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Necrotizing cholangitis, phlebothrombosis of lower extremities [venous thrombosis].Right pulmonary venous thrombus.Case description: initial information received on 07-may-2015: this spontaneous case report was received from a physician via company distributor and it concerned a (b)(6) year-old female patient affected by multiple hepatocellular carcinoma (hcc).Patient's past medical history included: nephrosis and spinal stenosis.Patient's concomitant drug was gelpart (porous gelatine particles, 1 mm).On (b)(6) 2015, the patient underwent transcatheter arterial chemoembolization (tace) using drug-eluting dc bead (100-300 microm) loaded with 60 mg of epirubicin hydrochloride.Dc bead loaded with epirubicin (0.35 vial) was injected into multiple hepatocellular carcinoma (hcc) through the right inferior phrenic artery.Dc bead loaded with epirubicin and gelpart was injected through distal of a5 (0.2 vial) and through cholecystic artery (0.05 vial).On (b)(6) 2015 patient laboratory data were: total bilirubin 0.7mg/dl (normal range: 0.2-1.Omg/dl), direct bilirubin 0.1mg/dl (normal range: 0.0-0.2 mg/dl), ast 27 iu/l (normal range: 10-35 iu/l), alt 221u/l (normal range: 5-40), ldh 274 iu/l (normal range: 120-240lu/l), al-p 209 iu/l ( normal range 115-359 iu/l), gamma-gt 54 iu/l (normal range: <30 iu/l ), ck 95 lu/l (normal range 44-170 iu/l), wbc 6 10 10a3/microl (normal range: 4.00-9.00), and crp 0.22 mg/dl (normal range: <0.30).On (b)(6) 2015, total bilirubin was 1.2 mg/dl, direct bilirubin was 0.2 mg/dl, ast was 505 iu/l, alt was 359 iu/l, ldh was 1376 iu/l, al-p 317 iu/l, gamma-gt was 65 iu/l, wbc was 14.70 10a3/microl and crp was 2.02 mg/dl.On (b)(6) 2015, the patient presented necrotizing cholangitis diagnosed on ct-scan, which required hospitalisation.Patient's laboratory data on (b)(6) 2015 were: total bilirubin 1.6 mg/dl, direct bilirubin 0.4 mg/dl, ast 403 iu/l, alt 370 iu/l, ldh 1034 iu/l, gamma-gt 71 iu/l, al-p 316 iu/l, ck 690 iu/l, wbc 10.7 10a3/microl, and crp 6.06 mg/dl.Since the patient presented a phlebothrombosis of lower extremities and right pulmonary venous thrombus, percutaneous drainage under ct scan was performed, without cholecystectomy.Meropenem 3g per day was also given.No progression to peritonitis was noted.On (b)(6) 2015, necrotizing cholangitis was improving under treatment.The patient was in relatively stable condition.Decannulation was scheduled.Patient's laboratory data on (b)(6) 2015 were: total bilirubin: 1.0 mg/dl, direct bilirubin: 0.2 mg/dl, ast: 16 iu/l, alt: 15 lu/l, ldh: 220 iu/l, gamma-gt: 98 iu/l, wbc 12.90 10a3/microl and crp 4.47 mg/dl.(other laboratory data reported in the laboratory data section).The physician assessed the necrotizing cholangitis as probably related to the embolization of cholecystic artery, and the phlebothrombosis of lower extremities and right pulmonary venous thrombus as not related to dcbead.Follow-up information received on (b)(6) 2015: information on sales data for dc bead was provided and added in case comment.Case comment: necrotizing cholangitis, phlebothrombosis of lower extremities and right pulmonary venous thrombus are considered unlisted according to dc bead current instruction for use.The physician considered only the event necrotizing cholangitis as related to the use of dc bead.This single case report does not modify the risk benefit balance of dc bead.The company is continuously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis the first sales for dc bead in the (b)(6) were in 2004.Sales data from (b)(6) 2010 for dc bead is: eu 116.815 vials and row 59.919 vials.The follow-up information received on 23-jun-2015 did not change the case assessment.
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Manufacturer Narrative
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Dc bead with epirubicin hydrochloride was reported to have been used in the treatment of this patient.The equivalent product lc bead is available in the usa and is indicated for the treatment of hypervascular tumors and avms.The use of dc bead with epirubicin hydrochloride is considered off-label use.The device has not been sent to the manufacturer for evaluation.No batch review was possible for this case as the lot number could not be ascertained.No product malfunction/deficiency has been identified.
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Event Description
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Necrotizing cholangitis [cholangitis], phlebothrombosis of lower extremities [venous thrombosis], right pulmonary venous thrombus [pulmonary venous thrombosis], embolization of cholecystic artery [procedural complication].Case description: initial information received on (b)(6) 2015: this spontaneous case report was received from a physician via company distributor and it concerned a (b)(6) female patient affected by multiple hepatocellular carcinoma (hcc).Patient's past medical history included: nephrosis and spinal stenosis.Patient's concomitant drug was gelpart (porous gelatine particles, 1 mm).On (b)(6) 2015, the patient underwent transcatheter arterial chemoembolization (tace) using drug-eluting dc bead (100-300 microm) loaded with 60 mg of epirubicin hydrochloride.Dc bead loaded with epirubicin (0.35 vial) was injected into multiple hepatocellular carcinoma (hcc) through the right inferior phrenic artery.Dc bead loaded with epirubicin and gelpart was injected through distal of a5 (0.2 vial) and through cholecystic artery (0.05 vial).On (b)(6) 2015 patient laboratory data were : total bilirubin 0.7mg/dl (normal range: 0.2-1.0mg/dl), direct bilirubin 0.1mg/dl (normal range: 0.0-0.2 mg/dl), ast 27 iu/l (normal range: 10-35 iu/l), alt 22iu/l (normal range: 5-40), ldh 274 iu/l (normal range: 120-240iu/l), al-p 209 iu/l ( normal range 115-359 iu/l), gamma-gt 54 iu/l (normal range: <30 iu/l ), ck 95 iu/l (normal range 44-170 iu/l), wbc 6.10 10^3/microl (normal range: 4.00-9.00), and crp 0.22 mg/dl (normal range: <0.30).On (b)(6) 2015, total bilirubin was 1.2 mg/dl, direct bilirubin was 0.2 mg/dl, ast was 505 iu/l, alt was 359 iu/l, ldh was 1376 iu/l, al-p 317 iu/l, gamma-gt was 65 iu/l, wbc was 14.70 10^3/microl and crp was 2.02 mg/dl.On (b)(6) 2015, the patient presented necrotizing cholangitis diagnosed on ct-scan, which required hospitalisation.Patient's laboratory data on (b)(6) 2015 were: total bilirubin 1.6 mg/dl, direct bilirubin 0.4 mg/dl, ast 403 iu/l, alt 370 iu/l, ldh 1034 iu/l, gamma-gt 71 iu/l, al-p 316 iu/l, ck 690 iu/l, wbc 10.7 10^3/microl, and crp 6.06 mg/dl.Since the patient presented a phlebothrombosis of lower extremities and right pulmonary venous thrombus, percutaneous drainage under ct scan was performed, without cholecystectomy.Meropenem 3g per day was also given.No progression to peritonitis was noted.On (b)(6) 2015, necrotizing cholangitis was improving under treatment.The patient was in relatively stable condition.Decanulation was scheduled.Patient's laboratory data on (b)(6) 2015 were: total bilirubin: 1.0 mg/dl, direct bilirubin: 0.2 mg/dl, ast: 16 iu/l, alt: 15 iu/l, ldh: 220 iu/l, gamma-gt: 98 iu/l, wbc 12.90 10^3/microl and crp 4.47 mg/dl.(other laboratory data reported in the laboratory data section).The physician assessed the necrotizing cholangitis as probably related to the embolization of cholecystic artery, and the phlebothrombosis of lower extremities and right pulmonary venous thrombus as not related to dcbead.Follow-up information received on 23-jun-2015: information on sales data for dc bead was provided and added in case comment.Follow up information received on 29-jun-2015: on (b)(6) 2015, tace was performed using dc bead (1 vial of 100-300 um) loaded with 60 mg of epirubicin for multiple hcc in the right hepatic lobe.Gelpart (1 mm) once was used for occlusion of shunts.Epirubicin loaded dc bead with gelpart was injected through distal of a5 (0.2 vial) and cholecystic artery (0.05 vial).Method and results of the examination for collateral circulation and shunt via abdominal angiography: left femoral arterial puncture was performed by seldinger techniques (approach from the right side was unavailable due to arteriosclerosis), 4 fr.Shepherd hook catheter was advanced to the celiac artery to perform digital subtraction angiography (dsa).Arterio-portalshunt (a-p shunt) and tumor stain were seen in the right hepatic lobe.The guiding catheter was replaced by a cobra catheter, and hanaco michibiki plus 1.8 fr.Microcatheter was advanced to the right inferior phrenic artery and imaged.A number of tumor stains were observed, but the a-p shunt from the same blood vessel seen in the previous angiography had disappeared, and embolization was performed using dc bead loaded with epirubicin.After the embolization, the tumor stains decreased.Then, when the catheter was advanced to the right hepatic artery, and dsa was performed, the a-p shunt point was seen in two points from peripheral a5 and one point from the peripheral cystic artery.The microcatheter was advanced to near the points, and shunt occlusion was performed by administration of gelpart 1 mm, and then embolization with beads was performed.In angiography after embolization, slight tumor stains remained around the main stem of right hepatic artery, and these were nourished by fine blood vessels directly bifurcating from the main stem, and therefore selective embolization was difficult.The image of the ap-shunt had disappeared.In dynamic ct, the drug was being retained (the lesion was likely to have a necrotic tendency, and the drug was being retained inside in the septum-like part).The reporting physician commented that the event necrotizing cholangitis was considered due to the embolization of cholecystic artery.Case comment: necrotizing cholangitis, phlebothrombosis of lower extremities and right pulmonary venous thrombus are considered unlisted according to dc bead current instruction for use.Procedural complication is a potential risk associated with the use of dc bead according to the current instruction for use.The physician considered only the event necrotizing cholangitis as related to the use of dc bead.This single case report does not modify the risk benefit balance of dc bead.The company is continously monitoring all respective reports received, and based on cumulative experience, will re-evaluate the available evidence on an ongoing basis the first sales for dc bead in the uk were in 2004.Sales data from jan-2010 for dc bead is: eu 116.815 vials and row 59.919 vials.The follow-up information received on 23-jun-2015 did not change the assessment of the case the follow up information received on 29-jun-2015 did not change the assessment of the case.Final assessment received on 23-dec-2015: the company considered the event of cholangitis as not related dc beads but related to the embolization of the cholecystic artery which was a procedural complication.The company considers the events of venous thrombosis and pulmonary venous thrombosis as not related to dc beads.No further follow up information is expected.No device failure has been identified as a result of this adverse event.It has been assessed that no corrective action is necessary at this time.This report is considered final.The case is closed.
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