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

Model Number 26924

Device Problems Difficult to Remove (1528); Migration (4003)

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

Event Date 08/06/2021

Event Type  Injury  

Event Description

It was reported that stent migration occurred requiring additional intervention.The external iliac was calcified.A 8x80mm innova vascular stent was advanced via a contralateral approach.The stent was deployed without issue, however, when removing the delivery system, the nosecone became stuck on the stent.The stent popped into the aorta.A 10x40mm mustang balloon was dilated above the innova stent and used to pull the stent into the right iliac artery.Then, two (2) 8x57mm express ld stents were deployed in the left and right common iliac artery, trapping the innova stent in the left iliac artery.The patient tolerated the procedure without issues.

Event Description

It was reported that stent migration occurred requiring additional intervention.The external iliac was calcified.A 8x80mm innova vascular stent was advanced via a contralateral approach.The stent was deployed without issue, however, when removing the delivery system, the nosecone became stuck on the stent.The stent popped into the aorta.A 10x40mm mustang balloon was dilated above the innova stent and used to pull the stent into the right iliac artery.Then, two (2) 8x57mm express ld stents were deployed in the left and right common iliac artery, trapping the innova stent in the left iliac artery.The patient tolerate the procedure without issues.

Manufacturer Narrative

H3 - device evaluated by manufacturer: returned product consisted of an innova self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed that the inner liner is separated 14.1cm from the tip.Microscopic examination revealed marks on the proximal end of the tip.The device was disassembled to verify if there was any additional damages inside the handle.No additional damages were found.

• Brand Name: INNOVA VASCULAR
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12375156
• MDR Text Key: 268441795
• Report Number: 2134265-2021-10555
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729874195
• UDI-Public: 08714729874195
• Combination Product (y/n): N
• PMA/PMN Number: P140028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0023575659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Date Manufacturer Received: 09/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR