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

Model Number	H74939293061830
Medical Device Problem Codes	Stretched (1601); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that the stent was partially deployed and damaged.The 100% stenosed target lesion was located in a severely calcified and moderately tortuous superficial femoral artery (sfa).The innova¿ was introduced via a contralateral approach.The lesion was crossed using non-bsc guidewire and the 6 x 180 x 130 innova¿ was then advanced along the guidewire from the opposite side to the same side of the lesion.The innova¿ was then was advanced to the target lesion and placement was attempted.Deployment was successfully initiated and deployed about 5cm then the thumbwheel stopped working and deployment stopped.The physician tried to deploy the stent with the pull grip, however resistance was encountered and 10cm of the stent was deployed.The entire system was then pulled, and all of the stent was deployed successfully.The stent was then checked under fluoroscopy and the strut appeared damaged.No patient complications were reported and the procedure was completed with this device.
Additional Manufacturer Narrative
Device evaluated by manufacturer: returned product consisted of an innova self-expanding stent delivery system (sds).The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The shaft was kinked at the nosecone.There was a kink on the inner liner approximately 14.5 cm from the tip.The stent was not returned.The handle was opened to investigate for further damage.There was no further damage on the inside of the handle.The mid-shaft was cut to pull out of the outer sheath to inspect for wrinkles that may cause deployment difficulties.No issues were found on the mid-shaft.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
It was reported that the stent was partially deployed and damaged.The 100% stenosed target lesion was located in a severely calcified and moderately tortuous superficial femoral artery (sfa).The innova¿ was introduced via a contralateral approach.The lesion was crossed using non-bsc guidewire and the 6 x 180 x 130 innova¿ was then advanced along the guidewire from the opposite side to the same side of the lesion.The innova¿ was then was advanced to the target lesion and placement was attempted.Deployment was successfully initiated and deployed about 5 cm then the thumbwheel stopped working and deployment stopped.The physician tried to deploy the stent with the pull grip, however resistance was encountered and 10 cm of the stent was deployed.The entire system was then pulled, and all of the stent was deployed successfully.The stent was then checked under fluoroscopy and the strut appeared damaged.No patient complications were reported and the procedure was completed with this device.

• 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: 6463180
• Report Number: 2134265-2017-02733
• Device Sequence Number: 591641
• Product Code: NIP
• UDI-Device Identifier: 08714729874058
• UDI-Public: (01)08714729874058(17)20190930(10)0019752067
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2017

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: 09/30/2019
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 0019752067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2017
• Supplement Report FDA Received Date: 05/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1