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

Model Number 26924

Device Problem Material Integrity Problem (2978)

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

Event Date 03/18/2021

Event Type  malfunction  

Event 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 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.

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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11651985
• MDR Text Key: 245100275
• Report Number: 2134265-2021-04503
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• 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: 05/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 05/06/2021
• Patient Sequence Number: 1
• Patient Age: 90 YR