MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE INNOVA¿; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	H74939293061230
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	04/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not retuned for analysis.The investigation conclusion is anticipated procedural complication as the event is due to a known physiological effect of the procedure noted within the directions for use, and/or device labeling.(b)(4).
Event or Problem Description
Same case as mdr id: 2134265-2018-04458.It was reported that in-stent restenosis occurred.On (b)(6) 2017, the index procedure was performed.The patient presented with critical ischemia, rest pain, gangrene, non-healing ulcers, and amputation of toe.An angiogram of the right leg showed that the right popliteal artery was 70% stenosed and the right superficial femoral artery was 60% stenosed.A 5mm by 150mm innova stent was implanted in the right popliteal artery and post-dilated with a 5mm by 200mm non-bsc balloon.Pretreatment stenosis was 70% and post treatment stenosis was 0%.A 6mm by 120mm innova stent was implanted in the right superficial femoral artery and post-dilated with a 6mm by 150mm non-bsc balloon.Pretreatment stenosis was 60% and post treatment stenosis was 0%.There were no complications and there was significant improved runoff and foot perfusion post intervention.On (b)(6) 2018, the patient presented with in-stent restenosis of both innova stents.Atherectomy was performed using a bsc jetstream 2.4mm atherectomy catheter, followed by balloon angioplasty with a 5mm by 150mm bsc sterling balloon.The vessels were patent post procedure.There were no patient complications and patient was in good condition post-procedure.

• Brand Name: INNOVA¿
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 7535435
• Report Number: 2134265-2018-04459
• Device Sequence Number: 13831094
• Product Code: NIP
• UDI-Device Identifier: 08714729874034
• UDI-Public: 08714729874034
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: H74939293061230
• Device Catalogue Number: 39293-06123
• Device Lot Number: 0020247010
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/27/2018
• Initial Report FDA Received Date: 05/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR