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

Model Number	26924
Medical Device Problem Codes	Difficult to Remove (1528); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2021
Type of Reportable Event	Serious Injury
Event or Problem 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 or Problem 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.
Additional 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
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12375156
• Report Number: 2134265-2021-10555
• Device Sequence Number: 3935333
• Product Code: NIP
• UDI-Device Identifier: 08714729874195
• UDI-Public: 08714729874195
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 09/10/2021
• Initial Report FDA Received Date: 08/26/2021
• Supplement Report FDA Received Date: 09/24/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR