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

Model Number	H74939293051530
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of the event: 18 years or older.(b)(4).Device evaluated by mfr: 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.  bsc id: (b)(4).Tw#: (b)(4).
Event or Problem Description
It was reported that stent foreshortening occurred.A 5x150x130 innova¿ stent was selected for an intervention in the patient's superficial femoral artery (sfa).The lesion was 90% stenosed, minimally tortuous, and moderately calcified.Antegade access was gained to the lesion and pre-dilatation was performed.There was no difficulty deploying the stent, however, during deployment the stent started to compress and it shortened.The stent measured 80 mm post-deployment (visual estimation).No damage was noted on the stent.Post-dilatation was performed after the stent was deployed.Because the stent was assessed to be shortened, a 5x60 innova¿ stent was used to cover the rest of the lesion.No patient complications were reported.The patients status after the procedure was fine.

• 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: 7660612
• Report Number: 2134265-2018-05917
• Device Sequence Number: 16773042
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: H74939293051530
• Device Catalogue Number: 39293-05153
• Device Lot Number: 18362994
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 07/03/2018
• 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