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

Model Number	H74939293072030
Medical Device Problem Code	Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age at time of event: 18 years or older.(b)(4).Device evaluated by manufacturer: the complaint device was not returned.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the superficial femoral artery (sfa).A 7 x 200 x 130 innova¿ was selected for use after another innova¿ was previously deployed in the distal sfa without issues.After 150 cm of the 7 x 200 x 130 innova¿ was deployed, the remaining 50 cm of the stent began to elongate.This caused the stent to go from the proximal sfa up to the common femoral region covering the profunda.The procedure was completed with this stent with no intervention taken to the stent.There were no patient complications and the patient is 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: 6429927
• Report Number: 2134265-2017-02316
• Device Sequence Number: 16278834
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: (01)08714729874157(17)20180731(10)18168041
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2018
• Device Model Number: H74939293072030
• Device Catalogue Number: 39293-07203
• Device Lot Number: 18168041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2017
• Initial Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1