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

Model Number 26929

Device Problems Defective Device (2588); Positioning Problem (3009)

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

Event Date 03/10/2023

Event Type  malfunction  

Manufacturer Narrative

Media analysis: the complaint device was not received at the complaint investigation site for analysis.However, media was provided in the form of three photos.One of the photos showed that the stent was still constrained in the sheath.There appeared to be some sort of measurement scale/ruler that went from 11-19.The distal end of the stent was somewhere around the 19 and the proximal end was around the 11.The second photo was the shelf box.The third photo was the stent post deployment.It only showed the proximal section of the stent.The measurement scale/ruler was visible from 3-13.The proximal end of the stent appeared to end at around the five.It could not be determined where the distal end of the stent was from the photo.The stent appeared to fade toward the distal end.

Event Description

It was reported that the stent did not deploy in the intended location and appeared longer once deployed than on pre-deployment imaging.An innova vascular stent was selected for use during the percutaneous angioplasty procedure.The target location was located within the mid superficial femoral artery (sfa) and was reported to be 75% stenosed with moderate-to-severe calcification.The stent delivery system was advanced to the target lesion, and the stent was positioned by identifying both the proximal and distal ends on imaging.The stent was deployed slowly and deliberately, and the proximal end landed far more proximal than the pre-deployment imaging had indicated.The stent appeared much longer than originally visualized.Following stent deployment, a potential arteriovenous fistula (avf) was observed laterally.The avf was not suspected to be related to the innova vascular stent.A charger balloon dilation catheter was inflated to address the avf.The procedure was completed, and there were no reported adverse consequences to the patient.

• 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: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16679166
• MDR Text Key: 312705159
• Report Number: 2124215-2023-15758
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874034
• UDI-Public: 08714729874034
• 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: 04/04/2023

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: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0024712971
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2023
• Initial Date FDA Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CHARGER BALLOON DILATION CATHETER