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

Model Number	H74939293086030
Medical Device Problem Codes	Bent (1059); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).
Event or Problem Description
It was reported that during a left external iliac artery angioplasty and stenting procedure, stent deployment issues and stent damage occurred.Vascular access was obtained via a contralateral approach.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified left external iliac artery.After predilation, a 8mm-60mm/130cm innova¿ stent was advanced to the target lesion.The thumbwheel was turned with normal force but it locked up when the stent was deployed about 30mm.The pull grip was used but it also locked up and would not deploy the last half of the stent.The stent was pulled out of the body and it was stretched.The procedure was aborted.No patient complications were reported and the patient's status was fine.
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 middle shaft had no damage.The shaft of the device was stuck inside the returned introducer sheath, with the stent was partially deployed sticking out of the end of the introducer sheath.The stent did show some damage.The handle was separated to inspect for further damage.There was no damage noticed.Inspection of the remainder of the device 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 cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).
Event or Problem Description
It was reported that during a left external iliac artery angioplasty and stenting procedure, stent deployment issues and stent damage occurred.Vascular access was obtained via a contralateral approach.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified left external iliac artery.After predilation, a 8mm-60mm/130cm innova¿ stent was advanced to the target lesion.The thumbwheel was turned with normal force but it locked up when the stent was deployed about 30mm.The pull grip was used but it also locked up and would not deploy the last half of the stent.The stent was pulled out of the body and it was stretched.The procedure was aborted.No patient complications were reported and the patient's status was fine.

• 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: 6175689
• Report Number: 2134265-2016-11634
• Device Sequence Number: 358834
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: (01)08714729874188(17)20190531(10)19277255
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/29/2016

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: 05/31/2019
• Device Model Number: H74939293086030
• Device Catalogue Number: 39293-08603
• Device Lot Number: 19277255
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/29/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/15/2016
• Supplement Report FDA Received Date: 01/20/2017
• 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: .035 UNKNOWN GUIDEWIRE; INTRODUCER SHEATH: 6FR COOK
• Patient Age: 77 YR