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

Model Number	H74939293061830
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at the time of the event: 18 years or older (b)(4).Device evaluated by mfr: returned product consisted of an innova¿ stent for damage.Visual examination showed a kink at the nosecone.The mid-shaft showed multiple areas of kinks and twists.The stent was returned in the device.With the damage on the mid-shaft which houses the stent, most likely the stent would suffer damage due to the damage 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 stent damage occurred.An innova¿ stent was selected for a procedure in the superficial femoral artery (sfa).The target lesion was located in a severely tortuous anatomy with 100% stenosis and the lesion was severely calcified.Contralateral approach was performed in the sfa.Pre dilation was performed using a mustang balloon.After approaching the iliac from the opposite side, the sheath bounced at the approached part into the aorta when trying to deliver the innova¿.The stent was kinked and the device was retrieved at this time.The procedure was completed with another of the same device.There were no patient complications reported.

• 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: 6670946
• Report Number: 2134265-2017-06236
• Device Sequence Number: 1080334
• Product Code: NIP
• UDI-Device Identifier: 08714729874058
• UDI-Public: (01)08714729874058(17)20190831(10)19664968
• Combination Product (Y/N): N
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2017

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: 08/31/2019
• Device Model Number: H74939293061830
• Device Catalogue Number: 39293-06183
• Device Lot Number: 19664968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2017
• Initial Report FDA Received Date: 06/27/2017
• 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: GUIDEWIRE-35 RADIFOCUS; INTRODUCER SHEATH- PARENT 45CM