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

Model Number	26924
Medical Device Problem Codes	Break (1069); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that shaft break and premature deployment occurred.The patient was being treated for renal stenosis.After placing a 6.5 non-boston scientific guiding sheath, a 7 x 20 x 130 innova vascular stent was advanced for treatment.However, during introduction, the device fractured inside the patient and the stent prematurely deployed in the sheath.The stent was snared, and another 7 x 20 x 130 innova vascular stent was successfully advanced in a larger sheath.The procedure was completed.No patient complications were reported.
Additional Manufacturer Narrative
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 a kink to the sheath at the nosecone.There is buckling to the middle sheath 4mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack are still in the manufactured position.The stent is not inside the sheath and appears to be missing.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 that shaft break and premature deployment occurred.The patient was being treated for renal stenosis.After placing a 6.5 non-boston scientific guiding sheath, a 7 x 20 x 130 innova vascular stent was advanced for treatment.However, during introduction, the device fractured inside the patient and the stent prematurely deployed in the sheath.The stent was snared, and another 7 x 20 x 130 innova vascular stent was successfully advanced in a larger sheath.The procedure was completed.No patient complications were reported.

• 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 shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18393299
• Report Number: 2124215-2023-70428
• Device Sequence Number: 2933024
• Product Code: NIP
• UDI-Device Identifier: 08714729874072
• UDI-Public: 08714729874072
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2024

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 Model Number: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0031956334
• 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: 12/07/2023
• Supplement Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/06/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown