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	03/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device was not returned 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 2134265-2018-02378 and mdr 2134265-2018-02377.It was reported that in-stent restenosis occurred.A 6 x 80 innova¿ stent and two 5 x 150 x 130 innova¿ stents were selected for the initial procedure on (b)(6) 2017.The patient presented with critical ischemia, gangrene of the toes and resting pain.Using ultrasound, it was noted that the right superficial femoral artery (sfa) was occluded and the right popliteal artery was occluded.The right popliteal artery was balloon dilated with a 5 x 200 non-bsc balloon.Pre-treatment stenosis was 100%.Post-treatment stenosis was 50% with dissection.A 5 x 150 innova stent was placed in the right popliteal artery.The stent was post dilated with a non-bsc 5 x 200 balloon.Post treatment stenosis was 0%.The right sfa was athrectomized with a boston scientific jetstream device.Pre-treatment stenosis was 100% with dissection and post-treatment was 90%.The right sfa was balloon dilated with a 5 x 200 non-bsc balloon.Post-treatment stenosis was 50% with dissection.A 5 x 150 innova stent was placed in the distal right sfa.The stent was post dilated with a non-bsc balloon.Post-treatment stenosis was 0%.A 6 x 80 innova stent was placed in the proximal right sfa.The stent was post dilated with a 6 x 100 non-bsc balloon.Pre-treatment stenosis was 50% with dissection and post treatment was 0%.The procedure had excellent results post intervention.The patient presented with in-stent restenosis of all three stents on (b)(6) 2018.Re-intervention was performed; a 2.4 jetstream device was used throughout the entire length of the stenosis (sfa through popliteal).The jetstream was used blades down and blades up as well as with balloon angioplasty.Post procedure the vessels were patent.There were no patient complications and the patient was doing well.

• 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: 7379838
• Report Number: 2134265-2018-02379
• Device Sequence Number: 2024274
• 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): 03/06/2018

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: 12/31/2019
• Device Model Number: H74939293051530
• Device Catalogue Number: 39293-05153
• Device Lot Number: 20061325
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 03/28/2018
• 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: 84 YR