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

Model Number	H74939293062030
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	02/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: returned product consisted of an innova self-expanding stent delivery system (sds) with a.014 giuidewire stuck in the device.The outer shaft, middle shaft, inner sheath and the remainder of the device were checked for damage.The shaft was kinked at the nosecone.The.014 guidewire that is stuck in the device is protruding from the tip approximately 1cm and protruding from the proximal end approximately 103cm.The tip also showed some damage from the guidewire being stuck.The stent was not returned.The device was viewed and the handle was opened to find additional damage.It was noticed that the proximal inner was prolapsed and the proximal clip was pulled out from the pull handle.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 difficulties and stent stretching occurred.Vascular access was obtained via right groin antegrade approach.The target lesion was located in the right superficial femoral artery (sfa).A 6mm-200mm/130cm innova stent was advanced to treat the lesion.After the thumbwheel was fully turned to the stop point, pin pull was used with the white deployment handle and the blue pull back handle over the wire.However the stent did not deploy and it took many additional technical steps to allow the stent to be safely deployed.The patient suffered no adverse consequences and the occluded target lesion became patent and technically good, but the origin of the profunda was covered as the stent was deployed at level of distal right common femoral artery and was stretched.Balloon catheter was used to open the stent intertice in area of this profunda to assure no issue and a sterile wire cutter was also used at one point in this case.

• 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: 6411684
• Report Number: 2134265-2017-02087
• Device Sequence Number: 16375100
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20191130(10)19942503
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/23/2017

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: 11/30/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 19942503
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2017
• Initial Report FDA Received Date: 03/16/2017
• 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