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

Model Number	26929
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the delivery system became stuck on the guidewire.Vascular access was obtained via rail access in the groin and popliteal.The target lesion was located in the superficial femoral artery (sfa).A.035 zipwire was put into position and then a 5 x 120 x 130 innova and a 5 x 100 x 130 innova were loaded over both ends of the wire and advanced to the treatment site.The stent delivery systems became stuck on the zipwire during advancement to the target lesion.While trying to remove one of the delivery systems, the stent began to deploy.The physician pushed the zipwire out of the patient enough that one of the stents was outside the patient and the physician was able to cut the wire.The rest of the wire and the second innova stent was able to be removed from the patient with no further complications.The procedure was completed with different devices.The patient was fine post procedure.Returned product consisted of an innova self expanding stent delivery system (sds).Visual examination showed a kink at the nosecone.No damage was noticed on the mid shaft.The yellow thumbwheel lock was intact on the device and the pull handle was in the start position.The stent was partially deployed approximately 3cm from the distal end of the markerband.The zipwire has a hydrophilic coating that is very lubricious when kept hydrated; however, if the coating is left to dry it becomes very sticky and the user may get the indication of a binding or a stickiness to the device when trying to manipulate it over the wire.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink at the nosecone was attributable to handling of the device.

• 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: 7783224
• Report Number: 2134265-2018-60101
• Device Sequence Number: 1012925
• Product Code: NIP
• UDI-Device Identifier: 08714729873945
• UDI-Public: 08714729873945
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/14/2018

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: 05/20/2021
• Device Model Number: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0022144107
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 08/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1