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

Model Number	H74939293064070
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/02/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that stent foreshortening occurred.The target lesion was 99% stenosed, mildly calcified and mildly torturous shunt.A 6 x 40 x 75mm innova¿ stent was advanced.The physician stretched and pulled the stent during deployment and the stent became shortened; the physician indicated it was not 4 cm in length.The shortened stent remained implanted and was well apposed to the vessel wall, but did not cover the entire lesion.A 6 x 60mm innova¿ stent was placed further in the initial stent, to cover the remainder of the lesion.There were no further patient complications.The patient¿s condition was stable.

• 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: 6335432
• Report Number: 2134265-2017-01353
• Device Sequence Number: 1106181
• Product Code: NIP
• UDI-Device Identifier: 08714729873631
• UDI-Public: (01)08714729873631(17)20191231(10)0020056690
• Combination Product (Y/N): N
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/02/2017

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2019
• Device Model Number: H74939293064070
• Device Catalogue Number: 39293-06407
• Device Lot Number: 0020056690
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2017
• Initial Report FDA Received Date: 02/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON CATHETER: IN STENT DILATION SYMMETRY 5×4; GUIDEWIRE: FUGA 0.018 150CM; INFLATION DEVICE USED: EVEREST
• Outcome Attributed to Adverse Event: Required Intervention