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

Model Number	26924
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was partially deployed and became fractured.This 8 x 80 x 75 innova vascular stent was selected for use in a superficial femoral artery (sfa) stenting procedure.The 70% stenosed sfa lesion was mildly calcified and mildly tortuous.During the procedure, the physician believed the stent was fully deployed using the thumbwheel; therefore, pulled on the catheter to remove it, but felt resistance.At that time, they felt a break in the stent at the proximal sfa.Post dilation of the lesion was performed, and the broken piece of stent was removed which was still attached to the catheter.A portion of the stent remained implanted.Additionally, it was thought that the stent had not been fully deployed before pulling out the catheter.There were no patient complications, and it was noted that there was no need for a future procedure at that time.
Event or Problem Description
It was reported that the stent was partially deployed and became fractured.This 8 x 80 x 75 innova vascular stent was selected for use in a superficial femoral artery (sfa) stenting procedure.The 70% stenosed sfa lesion was mildly calcified and mildly tortuous.During the procedure, the physician believed the stent was fully deployed using the thumbwheel; therefore, pulled on the catheter to remove it, but felt resistance.At that time, they felt a break in the stent at the proximal sfa.Post dilation of the lesion was performed, and the broken piece of stent was removed which was still attached to the catheter.A portion of the stent remained implanted.Additionally, it was thought that the stent had not been fully deployed before pulling out the catheter.There were no patient complications, and it was noted that there was no need for a future procedure at that time.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this innova vascular stent was returned with an unknown terumo sheath.The outer sheath, tip, inner sheath and the remainder of the device were inspected for damage.Visual examination revealed a kink to the outer sheath at the nosecone.There was buckling to the outer sheath 4cm and 4.7cm from the nosecone.The stent was separated, and it appeared that only approximately 4cm was returned.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17619188
• Report Number: 2124215-2023-45854
• Device Sequence Number: 2598830
• Product Code: NIP
• UDI-Device Identifier: 08714729873839
• UDI-Public: 08714729873839
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P140028
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2023

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 Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0030968018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/14/2023
• Supplement Date Received by Manufacturer: 09/14/2023
• Initial Report FDA Received Date: 08/24/2023
• Supplement Report FDA Received Date: 09/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown