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

Model Number	H74939293051530
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	11/09/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
Same case as mdr 2134265-2017-13134 and mdr 2134265-2017-13136.It was reported that in-stent restenosis occurred.On (b)(6) 2017, the index procedure was performed.The patient presented with critical ischemia, gangrene of the toes and resting pain the right leg.An angiogram of the right popliteal artery showed that it was occluded.An angiogram of the right superficial femoral artery (sfa) showed it was occluded.A 5x150 innova¿ stent was placed in the right popliteal artery.The stent was post-dilated with a non-bsc balloon.Pre-treatment stenosis was 50% and post-treatment stenosis was 0%.A 5x150 innova¿ stent was placed in the distal right sfa.The stent was post-dilated with a non-bsc balloon.Pre-treatment stenosis was 50% and post-treatment was 0%.A 6x80 innova¿ stent was placed in the proximal right sfa.The stent was post-dilated with a non-bsc balloon.Pre-treatment stenosis was 50% and post-treatment was 0%.The procedure had excellent results with palpable pulses post intervention.The patient condition was stable.On (b)(6) 2017, the patient presented with in-stent restenosis in both 5x150 innova¿ stents and the 6x80 innova¿ stent.An angiogram showed the right sfa was occluded and the right popliteal artery was occluded.The right sfa was balloon dilated with a non-bsc device resulting in post-treatment stenosis at 99%.The right popliteal artery was balloon dilated resulting in post-treatment stenosis at 99%.The right sfa was athrectomized with a boston scientific jetstream device resulting in post-treatment stenosis at 80%.The right popliteal artery was athrectomized with a boston scientific jetstream device resulting in post-treatment stenosis at 90%.The right sfa was balloon dilated with a boston scientific sterling balloon resulting in post-treatment stenosis at 50%.The right popliteal artery was balloon dilated with a boston scientific sterling balloon resulting in post-treatment stenosis at 50%.The right sfa was balloon dilated with a boston scientific sterling balloon resulting in post-treatment stenosis at 0%.The right popliteal artery was balloon dilated with a boston scientific sterling balloon resulting in post-treatment stenosis at 0%.The procedure had improved foot perfusion, doppler signals and warmth.The patient¿s condition was stable.

• 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: 7142764
• Report Number: 2134265-2017-13135
• Device Sequence Number: 1145034
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 12/05/2017

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: 11/30/2019
• Device Model Number: H74939293051530
• Device Catalogue Number: 39293-05153
• Device Lot Number: 20024145
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2017
• Initial Report FDA Received Date: 12/22/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR