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

Model Number	H74939293072030
Medical Device Problem Codes	Bent (1059); Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).
Event or Problem Description
It was reported that during a left superficial femoral artery stenting procedure, stent deployment issues and stent damage occurred.Vascular access was obtained via a contralateral approach.The target lesion was located in the very mildly tortuous and mildly calcified left superficial femoral artery (sfa).A 7mm-200mm/130cm innova¿ stent was advanced over a.035 non-bsc guidewire to the target lesion.The physician turned the thumbwheel with normal force until the white arrow was observed and then pulled the blue pull handle back, but it would not go further.There was still approximately 4mm of the stent remaining on the delivery system.Then while attempting to pull the delivery system back to release the remaining portion of the stent, the stent elongated from 200mm to approximately 300mm and came off the delivery system.The stent fractured in half.The stent was deployed well and did not jeopardize flow in profunda.A 7x150 non-bsc self-expanding stent was put across the elongated/fractured section of the stent, and essentially bridged the two good ends of the stent.The procedure was completed.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, inner shaft and the remainder of the device were checked for damage.There was a kink at the nosecone.There also was a kink at the transition of the mid-shaft approximately 20.5cm from the marker band.The stent was not returned inside of the device.The handle was separated to inspect for further damage.It was noticed that the mid-shaft was detached 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 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 superficial femoral artery stenting procedure, stent deployment issues and stent damage occurred.Vascular access was obtained via a contralateral approach.The target lesion was located in the very mildly tortuous and mildly calcified left superficial femoral artery (sfa).A 7mm-200mm/130cm innova¿ stent was advanced over a.035 non-bsc guidewire to the target lesion.The physician turned the thumbwheel with normal force until the white arrow was observed and then pulled the blue pull handle back, but it would not go further.There was still approximately 4mm of the stent remaining on the delivery system.Then while attempting to pull the delivery system back to release the remaining portion of the stent, the stent elongated from 200mm to approximately 300mm and came off the delivery system.The stent fractured in half.The stent was deployed well and did not jeopardize flow in profunda.A 7x150 non-bsc self-expanding stent was put across the elongated/fractured section of the stent, and essentially bridged the two good ends of the stent.The procedure was completed.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: 6145074
• Report Number: 2134265-2016-11181
• Device Sequence Number: 651039
• Product Code: NIP
• UDI-Device Identifier: 08714729874157
• UDI-Public: (01)08714729874157(17)20190930(10)19693528
• 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
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2019
• Device Model Number: H74939293072030
• Device Catalogue Number: 39293-07203
• Device Lot Number: 19693528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/05/2016
• Supplement Report FDA Received Date: 12/16/2016
• 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: CORDIS .035 STORQ; INTRODUCER SHEATH: 6FR DESTINATION
• Outcome Attributed to Adverse Event: Required Intervention