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

Model Number	26926
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
Type of Reportable Event	Malfunction
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11196843
• Report Number: 2134265-2021-00368
• Device Sequence Number: 11701306
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2021

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: 09/14/2025
• 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
• Initial Date Received by Manufacturer: 01/11/2021
• Supplement Date Received by Manufacturer: 02/12/2021
• Initial Report FDA Received Date: 01/19/2021
• Supplement Report FDA Received Date: 03/02/2021
• Patient Sequence Number: 1
• Patient Age: 72 YR