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

Model Number	26924
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment and premature deployment occurred.The patient underwent percutaneous transluminal angioplasty and stenting of the 90% stenosed target lesion located in the severely tortuous and severely calcified superficial femoral artery via contralateral approach.A 6f 45cm catapult guide sheath was advanced with difficulty over the iliac bifurcation followed by crossing a 035 non-boston scientific (bsc) guidewire into the lesion.Pre-dilatation was performed with a 5 x 220 sterling balloon catheter with 60% residual stenosis.A 6 x 60 x 130 innova vascular stent was advanced for treatment.It was noted that the guidewire was flushed with heparinized saline.However, during insertion, the stent got stuck on the guidewire and started to deploy outside the patient before ever getting into the sheath.The stent and the guidewire had to be removed together due to the wire being stuck in the sheath.The procedure was completed with a stiff zipwire and a 6 x 80 innova vascular stent.No patient complications were reported.
Additional Manufacturer Narrative
The device was returned for evaluation.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.Visual examination revealed a kink to the outer sheath at the nosecone.The stent is partially deployed 28mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The pull rack and yellow thumbwheel lock is still in the manufactured position.Device to device interaction test was performed and the device was able to track over a test guidewire with some resistance at the kinked location.Inspection of the remainder of the device, revealed no other damage or irregularities.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that device entrapment and premature deployment occurred.The patient underwent percutaneous transluminal angioplasty and stenting of the 90% stenosed target lesion located in the severely tortuous and severely calcified superficial femoral artery via contralateral approach.A 6f 45cm catapult guide sheath was advanced with difficulty over the iliac bifurcation followed by crossing a 035 non-boston scientific (bsc) guidewire into the lesion.Pre-dilatation was performed with a 5 x 220 sterling balloon catheter with 60% residual stenosis.A 6 x 60 x 130 innova vascular stent was advanced for treatment.It was noted that the guidewire was flushed with heparinized saline.However, during insertion, the stent got stuck on the guidewire and started to deploy outside the patient before ever getting into the sheath.The stent and the guidewire had to be removed together due to the wire being stuck in the sheath.The procedure was completed with a stiff zipwire and a 6 x 80 innova vascular stent.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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18743853
• Report Number: 2124215-2024-07429
• Device Sequence Number: 6249799
• Product Code: NIP
• UDI-Device Identifier: 08714729874003
• UDI-Public: 08714729874003
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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): 04/04/2024

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: 0028428256
• 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: 02/02/2024
• Supplement Date Received by Manufacturer: 03/08/2024
• Initial Report FDA Received Date: 02/20/2024
• Supplement Report FDA Received Date: 04/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE: .035 COOK ROAD RUNNER; GUIDEWIRE: .035 COOK ROAD RUNNER
• Patient Sex: Unknown