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

Model Number	H74939293061530
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	Reocclusion (1985)
Date of Event	10/19/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned for analysis.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).
Event or Problem Description
Same case as mdr 2134265-2017-11104 and mdr 2134265-2017-11106.It was reported that in stent restenosis occurred.On (b)(6) 2016 the patient presented with atherosclerosis of native arteries of extremities with rest pain in the left leg and the index procedure was performed.An angiogram of the left common femoral artery found that the left superficial femoral artery (sfa) and left popliteal artery were occluded.Following pre-dilation, a 6x150 innova stent was placed successfully in the left popliteal artery, followed by post-dilation.Pre-treatment stenosis was 50%, post-treatment stenosis was 0%.Following pre-dilation, a 6x150 innova stent was placed successfully in the distal left sfa, followed by post-dilation.Pre-treatment stenosis was 50%, post-treatment stenosis was 50%.Following pre-dilation, a 6x120 innova stent was placed successfully in the proximal left sfa, followed by post-dilation.Pre-treatment stenosis was 50%, post-treatment stenosis was 0%.There were excellent results in the three vessel runoff and improved dopplers.There were no patient complications reported and the patient¿s condition post procedure was stable.On (b)(6) 2017 the patient presented with atherosclerosis of native arteries of left leg with ulceration of other part of foot and the index procedure was performed.An angiogram of the left common femoral artery found that the left superficial femoral artery (sfa) and left popliteal artery were occluded.Following pre-dilation, a 6x60 innova stent was placed successfully in the left popliteal artery, followed by post-dilation.Pre-treatment stenosis was 50%, post-treatment stenosis was 0%.There was much improved foot perfusion and doppler signals post-intervention.There were no patient complications reported and the patient¿s condition post procedure was stable.On (b)(6) 2017, the patient presented with in-stent restenosis in the 6x150, the 6x120 and the 6x60 innova stents.Jetstream arthrectomy and angioplasty were performed for treatment.The stents were re-opened and the result was favorable.There were no patient complications.

• 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: 7042971
• Report Number: 2134265-2017-11105
• Device Sequence Number: 11007416
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• 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: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/24/2017

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: 09/30/2019
• Device Model Number: H74939293061530
• Device Catalogue Number: 39293-06153
• Device Lot Number: 19699239
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2017
• Initial Report FDA Received Date: 11/17/2017
• 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: 78 YR