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

Model Number	26924
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the stent prematurely deployed.A 7x40x130 innova self-expanding stent was selected for use and a contralateral approach was performed.While delivering the stent inside the patient, the stent prematurely deployed in the right common femoral artery.This was not the desired deployment location.It was noted the locking tool was in place the entire time.No further intervention was performed.There were no patient complications and flow was sustained.
Additional Manufacturer Narrative
Device eval.By manufacturer: upon receipt at our post market quality assurance laboratory, this innova self-expanding stent system was examined.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the sheath at the nosecone.There is a kink to the inner liner 3.2cm from the tip.Microscopic examination revealed no additional damages.The stent appears to have been deployed and was not returned for analysis.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage to the device that may have contributed to the premature deployment.
Event or Problem Description
It was reported the stent prematurely deployed.A 7x40x130 innova self-expanding stent was selected for use and a contralateral approach was performed.While delivering the stent inside the patient, the stent prematurely deployed in the right common femoral artery.This was not the desired deployment location.It was noted the locking tool was in place the entire time.No further intervention was performed.There were no patient complications and flow was sustained.

• 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: 11610636
• Report Number: 2134265-2021-04234
• Device Sequence Number: 3280601
• Product Code: NIP
• UDI-Device Identifier: 08714729874089
• UDI-Public: 08714729874089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 05/28/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/26/2025
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0025924507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2021
• Initial Date Received by Manufacturer: 03/12/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 05/28/2021
• Patient Sequence Number: 1