MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

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

Patient Problems Inflammation (1932); Occlusion (1984); Thrombosis/Thrombus (4440)

Event Date 06/08/2018

Event Type  Injury  

Manufacturer Narrative

Date of birth: patient was born in (b)(6).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is anticipated procedural complication as the adverse event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).

Event Description

It was reported that the patient experienced historical in-stent restenosis and critical limb ischemia.It was further reported that the patient experienced left toe amputations.It was historically reported that the patient was enrolled in the (b)(6) clinical trial with the patient identifier of (b)(6).The patient underwent treatment with the eluvia stent on (b)(6) 2017.The target lesion was located in the left mid superficial femoral artery (sfa).The lesion had a 4.43 mm and 4.74 mm reference vessel diameter proximally and distally, respectively.The lesion had a total length of 40mm.The target lesion was 70% occluded and was crossed through the true lumen.Pre-dilatation was performed using a 5.5mm balloon after which a 6x40mm eluvia stent was implanted.Post-dilatation was performed using a 5.5 mm balloon.Residual stenosis was 0%.On (b)(6) 2018 the patient was hospitalized for critical ischemia of the left foot (serious event).Medication was administered and interventional procedure was performed on (b)(6) 2018 (revascularization of the target vessel, percutaneous transluminal angioplasty-pta and dcb).Final percentage stenosis (visual estimate) was 0%.The event is currently assessed as ongoing.It was further reported that a non-bsc drug coated balloon had been used during the (b)(6) 2018 procedure.After the patient had that revascularization procedure, for the occlusive in-stent restenosis (isr) of the distal edge of the stent, the patient developed an infection on (b)(6) 2018 in the left foot (serious event).The patient presented to the emergency room on (b)(6) 2018 and exploration revealed an infection.The patient had been taking antibiotics (cefalexin and levofloxacin) since (b)(6) 2018.An amputation was performed (amputation of first finger and distal phalanges of the left and third toe of the left foot) and the patient was discharged on (b)(6) 2018.The physician felt that the first finger amputation was related to the study stent and with the isr.The investigator assessed the event as probably related to the procedure and to the eluvia stent, and as anticipated.The event is currently assessed as ongoing.

Manufacturer Narrative

A2: date of birth: patient was born in 1951.

Event Description

It was reported that the patient experienced historical in-stent restenosis and critical limb ischemia.It was further reported that the patient experienced left toe amputations.It was historically reported that the patient was enrolled in the eminent clinical trial with the patient identifier of (b)(6).The patient underwent treatment with the eluvia stent on (b)(6) 2017.The target lesion was located in the left mid superficial femoral artery (sfa).The lesion had a 4.43 mm and 4.74 mm reference vessel diameter proximally and distally, respectively.The lesion had a total length of 40mm.The target lesion was 70% occluded and was crossed through the true lumen.Pre-dilatation was performed using a 5.5mm balloon after which a 6x40mm eluvia stent was implanted.Post-dilatation was performed using a 5.5 mm balloon.Residual stenosis was 0%.On (b)(6) 2018 the patient was hospitalized for critical ischemia of the left foot (serious event).Medication was administered and interventional procedure was performed on (b)(6) 2018 (revascularization of the target vessel, percutaneous transluminal angioplasty-pta and dcb).Final percentage stenosis (visual estimate) was 0%.The event is currently assessed as ongoing.It was further reported that a non-bsc drug coated balloon had been used during the (b)(6) 2018 procedure.After the patient had that revascularization procedure, for the occlusive in-stent restenosis (isr) of the distal edge of the stent, the patient developed an infection on (b)(6) 2018 in the left foot (serious event).The patient presented to the emergency room on (b)(6) 2018 and exploration revealed an infection.The patient had been taking antibiotics (cefalexin and levofloxacin) since (b)(6) 2018.An amputation was performed (amputation of first finger and distal phalanges of the left and third toe of the left foot) and the patient was discharged on (b)(6) 2018.The physician felt that the first finger amputation was related to the study stent and with the isr.The investigator assessed the event as probably related to the procedure and to the eluvia stent, and as anticipated.The event is currently assessed as ongoing.It was further reported that the target lesion was located in the left distal sfa.It was classified as a tasc ii a lesion.On (b)(6) 2017, the subject was discharged to home with dual antiplatelet medication.On (b)(6) 2018, the subject visited the enrolling site due to worsening of the ulcer in the first toe and diabetic foot infection.Physical examination revealed edema in foot, ulcer with non-suppurative erythematous border on back of the first metatarsophalangeal.Dry necrosis of distal phalanges of 1st, 2nd, and 3rd toe.The subject was hospitalized on the same day for further evaluation and treatment.Of note, the subject had visited chronic critical ischemia unit previously due to ulcer in first toe and has now returned again due to worsening of the condition.On (b)(6) 2018, the subject underwent an intervention involving amputation of the first toe of the left foot and distal phalanges of the second and third toe with primary closure.Procedure was successfully completed without any signs of complication, bleeding or suppuration.The subject was prescribed with antibiotic and was recommended daily wound cleaning with betadine.Additionally, removal of stiches was proposed 10 days post intervention or when the wound gets dry.On (b)(6) 2018, the event was considered recovered/resolved with sequelae and was discharged on the same day.

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8070123
• MDR Text Key: 127124735
• Report Number: 2134265-2018-07512
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2018
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0020386455
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DRUG COATED BALLOON: PASSEO-18 LUX OF BIOTRONIK AG; DRUG COATED BALLOON: PASSEO-18 LUX OF BIOTRONIK AG; DRUG COATED BALLOON: PASSEO-18 LUX OF BIOTRONIK AG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR