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

Model Number	H74939293052030
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/11/2016
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, inner shaft and the remainder of the device were checked for damage.There was a kink at the nosecone.The mid shaft was kinked 43cm from the tip.The pull handle was bent and damaged.The stent was returned inside of the device, but partially deployed approximately 1cm out from the end of the distal end of the mid shaft.The handle was separated by the engineering team to inspect for further damage.It was noticed that the mid-shaft had separated from the retainer clip.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 device analysis completed on 11-nov-2016.It was reported that the stent failed to deploy.The target lesion was located in the superficial femoral artery (sfa).A 5 x 200 x 130 innova¿ stent was advanced to treat the lesion.However, during deployment, the physician made about 30 clicks on the thumb wheel but the outer sheath would not retract.The stent would not deploy and was not exposed at all.The device was removed from the patient's body and the procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was fine.However, returned device analysis revealed stent partial deployment and shaft detachment/separation.

• 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: 6141994
• Report Number: 2134265-2016-10824
• Device Sequence Number: 153669
• Product Code: NIP
• UDI-Device Identifier: 08714729873976
• UDI-Public: (01)08714729873976(17)20190831(10)0019540559
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 11/11/2016

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: H74939293052030
• Device Catalogue Number: 39293-05203
• Device Lot Number: 0019540559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• 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
• Patient Age: 65 YR