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

Model Number 26926

Device Problem Premature Activation (1484)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Event Description

It was reported that the stent inadvertently deployed.A 5mm x 150mm x 130cm innova was selected for use in a left leg arteriogram with angioplasty and stenting procedure.During preparation, the device was being flushed on the back table when the stent partially deployed.The device never entered the patient.The procedure was completed with another of the same device.No patient complications were reported.

Event Description

It was reported that the stent inadvertently deployed.A 5mm x 150mm x 130cm innova was selected for use in a left leg arteriogram with angioplasty and stenting procedure.During preparation, the device was being flushed on the back table when the stent partially deployed.The device never entered the patient.The procedure was completed with another of the same device.No patient complications were reported.

Manufacturer Narrative

Device evaluation by mfr: returned product consisted of the innova self-expanding stent system.Visual examination revealed a kink to the outer sheath at the nosecone.The stent was deployed and missing.There was blood present inside the sheath.The proximal section of the pull rack was separated and missing.The distal section was still inside the handle.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage which could have contributed to the reported event.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11196843
• MDR Text Key: 227749520
• Report Number: 2134265-2021-00368
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• Combination Product (y/n): N
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0026013090
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Date Manufacturer Received: 02/12/2021
• Patient Sequence Number: 1
• Patient Age: 72 YR