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

Model Number	H74939293071830
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	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that stent deployment difficulty and stent damage occurred.Vascular access was obtained via a contralateral approach.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).After predilation, a 7mm-180mm/130cm innova¿ stent was advanced to the target lesion.The thumbwheel used with normal force until the white arrow was visible.The stent was deployed without issue with the thumbwheel up to 12cm.Then the pull grip was attempted to be pulled, but it was very hard and could not pull at all.While removing the device, the stent was stretched and pulled out from the delivery system and implanted inside the patient's body.The 18cm stent was stretched to about 26cm.The procedure was completed.The pull grip was able to pull without resistance encountered post procedure.No patient complications were reported and the patient's condition was good.
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, inner shaft and the remainder of the device were checked for damage.The shaft showed no damage.The middle shaft showed no damage.The stent was not returned with the device.There were no kinks or damage throughout the catheters shaft.There was no evidence of any damage or irregularities contributing to the reported deployment difficulty.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 stent deployment difficulty and stent damage occurred.Vascular access was obtained via a contralateral approach.The 100% stenosed target lesion was located in the moderately tortuous and moderately calcified superficial femoral artery (sfa).After predilation, a 7mm-180mm/130cm innova¿ stent was advanced to the target lesion.The thumbwheel used with normal force until the white arrow was visible.The stent was deployed without issue with the thumbwheel up to 12cm.Then the pull grip was attempted to be pulled, but it was very hard and could not pull at all.While removing the device, the stent was stretched and pulled out from the delivery system and implanted inside the patient's body.The 18cm stent was stretched to about 26cm.The procedure was completed.The pull grip was able to pull without resistance encountered post procedure.No patient complications were reported and the patient's condition was good.

• 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: 6236387
• Report Number: 2134265-2016-12416
• Device Sequence Number: 709873
• Product Code: NIP
• UDI-Device Identifier: 08714729874140
• UDI-Public: (01)08714729874140(17)20190630(10)0019426954
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/14/2016

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: 06/30/2019
• Device Model Number: H74939293071830
• Device Catalogue Number: 39293-07183
• Device Lot Number: 0019426954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 01/26/2017
• 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: GUIDEWIRE: CRUISE 014 INCH; INTRODUCER SHEATH: 6FR DESTINATION