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

Model Number 26928

Device Problems Entrapment of Device (1212); Premature Activation (1484)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2018

Event Type  malfunction  

Event 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 9mm from the distal end of the markerband.The zip wire 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 my 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 7783202
• MDR Text Key: 117153738
• Report Number: 2134265-2018-60102
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873938
• UDI-Public: 08714729873938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2021
• Device Model Number: 26928
• Device Catalogue Number: 26928
• Device Lot Number: 0022231555
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1