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

Model Number 26924

Device Problems Premature Activation (1484); Difficult to Remove (1528); Difficult to Advance (2920)

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

Event Date 07/21/2023

Event Type  malfunction  

Event Description

It was reported that the stent was difficult to advance, difficult to remove, and partially deployed.This 6 x 40 x 130 innova vascular stent was selected for use in an arterial stent procedure for superficial femoral artery (sfa) stenosis.During the procedure, a non-boston scientific guidewire was used as a buddy wire in the sheath with the stent system and non-boston scientific guidewire.It was noted there was not enough room for both devices in the sheath and difficulties advancing occurred.Additionally, difficulties were encountered when removing the stent.While removing, the stent partially deployed at the sheath valve.The stent was fully removed manually, and the procedure was completed using the standard technique without the use of a buddy wire and another of the same device.There were no patient complications.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17408299
• MDR Text Key: 320069685
• Report Number: 2124215-2023-39922
• Device Sequence Number: 1
• Product Code: NIP
• 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: Physician
• Type of Report: Initial
• Report Date: 07/27/2023

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
• Device Operator: Health Professional
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2023
• Initial Date FDA Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1