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	02/26/2018
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 2134265-2018-02326.It was reported that in stent restenosis occurred.The patient presented with critical ischemia, rest pain and claudication.On (b)(6) 2017, the index procedure was performed.An ultrasound in the right popliteal artery was performed and revealed 50% stenosis with plaque and intimal hyperplasia.A 5x40 innova¿ stent was placed successfully in the right popliteal artery.Post-dilataion was performed with a non-bsc balloon.Post-treatment stenosis was 0%.The procedure was completed with a good result.There were no patient complications reported and the patient was stable.On (b)(6) 2018, the patient presented with in-stent restenosis in the innova stent.On (b)(6) 2018, atherectomy with a 2.4 mm jetstream® xc atherectomy catheter and balloon angioplasty were performed through the occluded stent.There was a great outcome and the stent was patent.This was confirmed through ivus.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: 7365729
• Report Number: 2134265-2018-02219
• Device Sequence Number: 19320040
• 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): 02/27/2018

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: 09/25/2020
• Device Model Number: H74939293054030
• Device Catalogue Number: 39293-05403
• Device Lot Number: 21177821
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 03/23/2018
• 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