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

Model Number	H74939293072030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an innova self-expanding stent delivery system (sds) and no other devices.The outer shaft, middle shaft, the inner liner and the remainder of the device were checked for damage.There was a kink at the nosecone.The inner liner had no damage.The middle shaft had no damage.The stent was partially deployed and sticking out of the device approximately 6.5mm from the marker band.The engineering team separated the handle to inspect for further damage.There was no damage noticed.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
Reportable based on the product analysis completed on 11 november 2016.It was reported the stent failed to deploy.During the implantation of an innova 7 x 200 x 130 over an.014 non bsc filter wire.The physician was using the thumb wheel to deliver the device, after approximately 15 clicks, the stent still had not begun to deploy outside of the catheter.The device was removed from the patient and exchanged for a 7x150x130 innova and the procedure was completed.No patient complications were reported.However, the returned product analysis revealed that the stent is partially deployed.

• 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: 6142256
• Report Number: 2134265-2016-10873
• Device Sequence Number: 18872441
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: (01)08714729874157(17)20180630(10)18152541
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/17/2016

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: 06/30/2018
• Device Model Number: H74939293072030
• Device Catalogue Number: 39293-07203
• Device Lot Number: 18152541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2016
• Initial Report FDA Received Date: 12/02/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1