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

Model Number	H74939293061870
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	10/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr.: the device was not returned for analysis.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 there was partial deployment and stent damage.A 6 x 180 x 75 innova¿ self-expanding stent was selected for an evt procedure in the mildly tortuous 100% stenosed superficial femoral artery (sfa).An ipsilateral antegrade approach was used to access the lesion.The lesion was 2 mm pre-dilated.The innova was inserted by a non-bsc guidewire, but it was not able to cross the lesion.It was able to cross the lesion after the guidewire was changed to a 0.35.The stent was deployed by the thumb wheel up to 12 cm without any resistance.After that, it was not able to perform pull back and deploy completely.The thumbwheel was used with normal force until the white arrow was visible.The pull grip was not used.The handle was disassembled and it was found that the stent was stretched and deployed in the sheath.The stent was able to be pushed into the target vessel.The procedure was completed with this device.The stent did not fracture and there were no kinks.There were no patient complications and the patient status 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: 6120195
• Report Number: 2134265-2016-10630
• Device Sequence Number: 1129405
• Product Code: NIP
• UDI-Device Identifier: 08714729873693
• UDI-Public: (01)08714729873693(17)20190331(10)19048089
• 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
• Report Date (Section B): 11/01/2016

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: 03/31/2019
• Device Model Number: H74939293061870
• Device Catalogue Number: 39293-06187
• Device Lot Number: 19048089
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2016
• Initial Report FDA Received Date: 11/22/2016
• 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: RAZIFORCUS/TERUMO; INTRODUCER SHEATH: PARENT 6FR 23CM