MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INNOVA VASCULAR; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	26926
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Age at time of event: older than 18 years.
Event or Problem Description
It was reported that the tip and inner shaft separated from the rest of the device.An innova stent was selected for use for a percutaneous transluminal angioplasty (pta) procedure in the left superficial femoral artery (sfa).The device was advanced contralateral and the stent was deployed without issue.When the physician was attempting to remove the system after stent placement, the inner shaft, including the distal tip, was found to be separated completely.There was no feeling of resistance.The inner shaft and distal tip remained on the guidewire, and the system was able to be removed completely from the body.There were no patient complications reported and the patient's status post procedure was fine.
Additional Manufacturer Narrative
Age at time of event: older than 18 years.
Event or Problem Description
It was reported that the tip and inner shaft separated from the rest of the device.An innova stent was selected for use for a percutaneous transluminal angioplasty (pta) procedure in the left superficial femoral artery (sfa).The device was advanced contralateral and the stent was deployed without issue.When the physician was attempting to remove the system after stent placement, the inner shaft, including the distal tip, was found to be separated completely.There was no feeling of resistance.The inner shaft and distal tip remained on the guidewire, and the system was able to be removed completely from the body.There were no patient complications reported and the patient's status post procedure was fine.Device evaluated by mfr: the outer sheath was kinked at the nosecone.The outer sheath showed some slight buckling 61.5cm from the nosecone.The mid shaft showed no damage.The inner liner showed a separation located at 39.5cm from the tip.The tip is part of the inner liner portion that was detached so the tip was detached from the device.The stent was not returned in the device.The handle was separated to inspect for further damage.The separations were caused by possible introducer sheath interference when the procedure was completed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7911600
• Report Number: 2134265-2018-61292
• Device Sequence Number: 16659980
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2018

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: 04/23/2021
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0022028058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2018
• Initial Date Received by Manufacturer: 09/13/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/26/2018
• Supplement Report FDA Received Date: 10/22/2018
• 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 - TERUMO RADIFOCUS 035; GUIDEWIRE - TERUMO RADIFOCUS 035; INTRODUCER SHEATH - MEDIKIT PARENT 6F; INTRODUCER SHEATH - MEDIKIT PARENT 6F