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

Model Number	H74939293086030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Perforation of Vessels (2135)
Date of Event	11/01/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 60¿s.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.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 information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported during a peripheral intervention of a vein bypass graft, stent fracture and vessel perforation occurred.Vascular access was obtained via femoral popliteal artery utilizing contralateral approach.The target lesion was located in the non-tortuous and non-calcified vein bypass graft with a reference vessel diameter of 7mm.After a non-bsc guidewire was passed through and pre-dilation was performed using a 5x40mm mustang balloon, a 8x60x130 innova¿ stent was advanced to the target lesion.Thumbwheel was turned with normal force.Post stent placement, it was noted that the stent fractured but still remained as one piece.Vessel perforation was confirmed by multiple angiographic images.Another 8x50 non-bsc stent was placed to cover the lesion.No further patient complications were reported and the patient's status was fine at this time.

• 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: 6116841
• Report Number: 2134265-2016-10547
• Device Sequence Number: 53002
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: (01)08714729874188(17)20180930(10)18428644
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 11/01/2016

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: Physician
• Device Expiration Date: 10/30/2016
• Device Model Number: H74939293086030
• Device Catalogue Number: 39293-08603
• Device Lot Number: 18428644
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/21/2016
• 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: 5X40MM MUSTANG BALLOON; GUIDEWIRE: 0.35X300 STORQ; INTRODUCER SHEATH: 6FR DESTINATION
• Outcome Attributed to Adverse Event: Required Intervention