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

Model Number 26926

Device Problem Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/17/2021

Event Type  Injury  

Event Description

It was reported that the stent was found to be shorter than what was labeled on the packaging, and additional intervention was required.An 8mm x 150mm x 130cm innova self-expanding stent was selected for use in a stenting procedure.During the procedure, the stent was implanted, but it was found to be shorter than what was labeled on the packaging.The implanted stent length was measured to be 110mm, which was 40mm shorter than expected.An additional 8mm x 60mm x 130mm stent was implanted with 10mm of overlap in order to cover the missed segment.The procedure was completed.No patient complications were reported.

• 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 CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11478975
• MDR Text Key: 239682534
• Report Number: 2134265-2021-03077
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874225
• UDI-Public: 08714729874225
• 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: 03/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0026289708
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2021
• Initial Date FDA Received: 03/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention