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

Model Number	H74939293062030
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Stretched (1601); Delivery System Failure (2905)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: 18 years or older.(b)(4).Device evaluated by mfr: the outer shaft, mid-shaft, inner shaft, proximal liner and the remainder of the device were checked for damage.A kink was noticed at the nosecone as well as multiple kinks throughout the outer shaft.The mid-shaft and the proximal inner shaft were completely separated from the handle, also with multiple kinks throughout its length.The proximal liner was separated from the handle.The inner liner was also separated from the handle with multiple kinks.The pull rack had come loose inside of the handle due to the mid-shaft coming loose from the retainer clip.The stent was not returned.The handle was separated and inspected for further damage.It was noticed that the mid-shaft was detached from the retainer clip.It was also noticed that the inner liner was separated from the cuff.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 damage and deployment difficulties occurred.The 50% stenosed, moderately calcified lesion was located in the superficial femoral artery (sfa).A 6 x 200 x 130 innova¿ was advanced to the sfa via a contralateral approach and deployment was initiated with the thumb wheel until the white arrow was visualized.Deployment was switched to the pull grip when there was difficulty pulling the knob to finish deployment and approximately 10cm of the stent elongated.The innova¿ delivery system was walked off the guide wire in 3 pieces; first the outer catheter was removed and then the inner catheter.The lesion was dilated with a balloon to complete the procedure.There were no patient complications 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: 6386004
• Report Number: 2134265-2017-01650
• Device Sequence Number: 744601
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: (01)08714729874065(17)20191231(10)20109861
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/13/2017

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: 12/31/2019
• Device Model Number: H74939293062030
• Device Catalogue Number: 39293-06203
• Device Lot Number: 20109861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/07/2017
• 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: ACCESS SHEATH: COOK ANSEL 7FR; GUIDE WIRE: MAGIC TORQUE .035"