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

Model Number	26924
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the tip fractured.A 6x40x130 innova self-expanding stent was selected for use to treat arterial stenosis in the left leg.Upon removal from the packaging a fracture to the distal tip was observed.The catheter sheath was noted to be moving freely.A new stent, same model, was opened and successfully delivered.There were no patient complications.
Event or Problem Description
It was reported the tip fractured.A 6x40x130 innova self-expanding stent was selected for use to treat arterial stenosis in the left leg.Upon removal from the packaging a fracture to the distal tip was observed.The catheter sheath was noted to be moving freely.A new stent, same model, was opened and successfully delivered.There were no patient complications.
Additional Manufacturer Narrative
Device eval by mfr: the 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 nosecone is separated.Microscopic examination revealed no additional damages.Inspection of the remainder of the device, revealed no other damage or irregularities.

• 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: 11651985
• Report Number: 2134265-2021-04503
• Device Sequence Number: 14366883
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/27/2021

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: 02/17/2026
• Device Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0026829745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/06/2021
• Initial Report FDA Received Date: 04/12/2021
• Supplement Report FDA Received Date: 05/27/2021
• Patient Sequence Number: 1