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

Model Number	H74939293062030
Medical Device Problem Codes	Bent (1059); Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Returned product consisted of an innova self-expanding stent delivery system (sds) and no other devices.The outer sheath, middle shaft, inner liner and the remainder of the device were examined for damage.The outer sheath showed a kink at the nosecone.The tip showed some damage in the form of stent strut marks.No additional damage was noticed.The stent was not returned in the device.The handle was opened to inspect for further damage.It was noticed that the inner liner was kinked at the cuff 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 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 stent deployment difficulties were encountered.The target lesion was 80-100% stenosed and medium to highly calcified and tortuous.Following pre-dilation, a 6x200x130mm innova¿ stent was advanced via an ipsilateral approach.The innova stent was tracked over a.014 guidewire and deployment was initiated with the thumb wheel.The pull grip was utilized to deploy the remainder of the stent; however, a ¿snap¿ was heard and the pull grip was no longer functional.The physician then performed multiple maneuvers in order to get the stent to release and removed the delivery system.The stent was stretched or elongated as a result of the deployment difficulties.The procedure was completed by ballooning inside of the innova.There were no patient complications.

• 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: 6601040
• Report Number: 2134265-2017-05916
• Device Sequence Number: 18894207
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20191130(10)20013959
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 04/18/2017

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: 11/30/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 20013959
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2017
• Initial Report FDA Received Date: 05/31/2017
• 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: GUIDE CATHETER: 6FR X45 COOK; GUIDEWIRE:.014 PLATINUM PLUS WIRE
• Patient Age: 75 YR