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

Model Number	H74939293064070
Medical Device Problem Codes	Premature Activation (1484); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 6x40x75 innova stent was selected for use.However, during preparation of the stent, it was noted that the distal end of the stent was partially deployed.The device never entered the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds) and no other devices.The outer shaft, middle shaft, and the remainder of the device were checked for damage.There was a kink at the nosecone.The outer shaft also had 2 additional kinks: 1st was at 44.5cm from the tip and the 2nd was at 55cm from the tip.The middle shaft had no damage.The stent that was returned inside of the mid-shaft was partially deployed approximately 6mm from the marker band.Although it was reported that the device was not used, the presence of blood at the stent area of the device is indicative of handling beyond simply un-packaging the device as was reported.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 6x40x75 innova¿ stent was selected for use.However, during preparation of the stent, it was noted that the distal end of the stent was partially deployed.The device never entered the patient's body.The procedure was completed with a different device.No patient complications were reported.

• 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: 6108342
• Report Number: 2134265-2016-10153
• Device Sequence Number: 16353421
• Product Code: NIP
• UDI-Device Identifier: 08714729873631
• UDI-Public: (01)08714729873631(17)20190831(10)19644371
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2016

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: 08/31/2019
• Device Model Number: H74939293064070
• Device Catalogue Number: 39293-06407
• Device Lot Number: 19644371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/21/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 12/13/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1