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

Model Number	H74939293054030
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	06/22/2017
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
It was reported that in-stent restenosis occurred.On (b)(6) 2017, the index procedure was performed.The patient presented with peripheral artery disease (pad), critical ischemia, rest pain, claudication, and weakness.An angiogram of the right leg showed that the right popliteal artery was occluded.The right popliteal artery was balloon dilated with a 2mm by 220mm bsc sterling balloon.Pre-treatment stenosis was 100% and post-treatment stenosis was 99%.The right popliteal artery was then atherectomized with a bsc jetstream2.1/3.0mm atherectomy catheter.Pre-treatment stenosis was 99% and post-treatment stenosis was 70%.The right popliteal artery was balloon dilated again with a 5mm by 200mm bsc sterling balloon.Pre-treatment stenosis was 70% and post-treatment stenosis was 50%.The distal right popliteal artery was balloon dilated again with a non-bsc 4mm by 150mm balloon.Pre-treatment stenosis was 50% and post-treatment stenosis was 0%.An angiogram of the right popliteal artery was performed and it was found that the remainder of the artery was 40% stenosed with calcification, plaque, and dissection.The right popliteal artery was catheterized and an intravascular ultrasound was performed.It was found that the artery was 50% stenosed with calcification, plaque, and dissection.The maximum outer wall diameter was 4mm.A 5mm x 40mm innova stent was then placed in the mid-right popliteal artery to the knee joint, using a 5mm x 200mm bsc sterling balloon.Pre-treatment stenosis was 50% with calcification, plaque, and dissection and post-treatment stenosis was 0%.There was a good result with strong pedal pulses post intervention.On (b)(6) 2017, the patient presented with critical ischemia, rest pain, and claudication.An angiogram of the right leg showed that the right superficial femoral artery (sfa) was 50% stenosed with calcification, plaque, and intimal hyperplasia.The right sfa was atherectomized using a bsc jetstream 2.4/3.4mm atherectomy catheter.Pre-treatment stenosis was 50% with calcification, plaque, and intimal hyperplasia, and post-treatment stenosis was 40%.The right sfa was balloon dilated with a 6mm x 150mm bsc sterling balloon.Pre-treatment stenosis was 40% and post-treatment stenosis was 40% with dissection.A 6mm x 150mm innova stent was placed in the right sfa, using a 6mm x150mm bsc sterling balloon.Pre-treatment stenosis was 40% with a dissection, and post-treatment stenosis was 0%.During the same procedure in-stent restenosis was observed in the previously placed 5mm x 40mm innova stent implanted on (b)(6) 2017.Angiogram was performed in the right leg and showed 90% restenosis in the right popliteal artery.The isr was treated with atherectomized using a bsc jetstream 2.4/3.4mm atherectomy catheter.Pre-treatment stenosis was 90% and post-treatment stenosis was 70%.The right popliteal artery was then dilated using a 5mm x150mm bsc sterling balloon.Pre-treatment stenosis was 70% and post-treatment stenosis was 0%.Intravascular ultrasound was performed in the right popliteal artery ad findings revealed 0% stenosis with calcification.The maximum outer wall diameter was 4mm.No further patient complications were reported.

• 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: 7495955
• Report Number: 2134265-2018-04219
• Device Sequence Number: 18915623
• Product Code: NIP
• UDI-Device Identifier: 08714729873907
• UDI-Public: 08714729873907
• 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): 04/17/2018

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: H74939293054030
• Device Catalogue Number: 39293-05403
• Device Lot Number: 0020279927
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2018
• Initial Report FDA Received Date: 05/08/2018
• 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: 85 YR