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

Model Number 26926

Device Problem Material Integrity Problem (2978)

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

Event Date 08/20/2021

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 08dec2021.A 6mm x 150mm x 130cm innova self-expanding stent was selected for use in a stenting procedure within the superficial femoral artery.Upon opening the package, the tip of the catheter looked defective.Another of the same device was used to complete the procedure.No patient complications were reported.However, device analysis revealed partial deployment of the stent.

Manufacturer Narrative

Device eval by manufacturer: the innova device was returned to boston scientific for analysis.The outer sheath, tip, and the remainder of the device were checked for damage.The catheter shaft showed no damage.The yellow thumbwheel lock was attached to the handle when returned; however, it was not attached in the correct rotation.The blue pull handle was partially pulled approximately 1cm from the handle body.The stent was partially deployed approximately 0.5cm.Inspection of the remainder of the device, apart from the observed issue, revealed no other issues or irregularities.The complaint was confirmed for partially deployed stent.

• 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: 13087652
• MDR Text Key: 282909542
• Report Number: 2134265-2021-16190
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874041
• UDI-Public: 08714729874041
• 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: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2021
• 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: 0026374314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1