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

Model Number	H74939293052030
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2016
Type of Reportable Event	Serious Injury
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 stent deployment issues and stent fractured occurred.The target lesion was located in the distal left superficial femoral artery (sfa) popliteal.A 5mm-200mm/130cm innova¿ stent was advanced to the target lesion and the distal portion of the stent opened at the distal sfa top lesion.While clicking the device all the way through the delivery system and pulling the blue tangent, the stent would not release from the delivery system.In an attempt to remove the device, the stent snapped in two.The four distal markers appeared in the access sheath.Another stent was used to compress the stent up against the side wall of the artery.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.The outer shaft showed buckling/damage at the nosecone.The remainder of the shaft showed multiple kinks.The middle shaft and the inner shaft were completely separated from the handle.There were also multiple kinks in the middle shaft and the inner shaft.The pull handle was deployed.The stent was not returned.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 stent deployment issues and stent fractured occurred.The target lesion was located in the distal left superficial femoral artery (sfa) popliteal.A 5mm-200mm/130cm innova¿ stent was advanced to the target lesion and the distal portion of the stent opened at the distal sfa top lesion.While clicking the device all the way through the delivery system and pulling the blue tangent, the stent would not release from the delivery system.In an attempt to remove the device, the stent snapped in two.The four distal markers appeared in the access sheath.Another stent was used to compress the stent up against the side wall of the artery.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: 6181382
• Report Number: 2134265-2016-11697
• Device Sequence Number: 955203
• Product Code: NIP
• UDI-Device Identifier: 08714729873976
• UDI-Public: (01)08714729873976(17)20190930(10)19750808
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 12/01/2016

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: H74939293052030
• Device Catalogue Number: 39293-05203
• Device Lot Number: 19750808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR