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

Model Number	26926
Medical Device Problem Codes	Fracture (1260); Premature Activation (1484); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/18/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that upon removal the stent fractured and a portion was left un-retrieved in the patient.An 5mm x 150mm x 130cm innova vascular self-expanding stent was chosen for a superficial femoral artery (sfa) angioplasty and stent placement to treat peripheral artery disease.The target lesion contained very high grade stenosis (possibly occluded) and was severely calcified.During the treatment, the innova stent catheter would not cross the lesion on first attempt.The physician removed the stent and exchanged the wire, and then the lesion was pre-dilated with a 4mm balloon before attempting to cross the lesion again.A second attempt to cross the lesion also failed, and upon removal the stent started to deploy and elongated across a portion of the diseased sfa before fracturing.Therefore, a portion of the stent remained in the patient un-retrieved and a portion came out with catheter.Further intervention was performed where three additional innova stents (5mm x 120mm, 5mm x 100mm, 6mm x 150mm) were deployed to cover the un-retrieved fractured portion of the stent and lesion.Subsequently, the sfa was opened with blood flow through all stent.The procedure was completed successfully using an alternative method without sequela.
Additional Manufacturer Narrative
Device eval by manufacturer: 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 lock and rack were not in the manufactured location.The stent was outside of the sheath and stretched.The stent was separated 11.3 cm and the other section of the stent was missing.There was multiple buckling to the outer sheath 80.8cm to 83.1cm from the nosecone.There was a kink to the outer sheath at the nosecone.There was a kink to the inner liner 1.8cm from the tip.Microscopic examination revealed damage to the middle sheath 2mm from the distal end, and the tip was damaged.Inspection of the remainder of the device revealed no other damage or irregularities.Product found damage on the device that could have contributed to the reported event.
Event or Problem Description
It was reported that upon removal the stent fractured and a portion was left un-retrieved in the patient.An 5mm x 150mm x 130cm innova vascular self-expanding stent was chosen for a superficial femoral artery (sfa) angioplasty and stent placement to treat peripheral artery disease.The target lesion contained very high grade stenosis (possibly occluded) and was severely calcified.During the treatment, the innova stent catheter would not cross the lesion on first attempt.The physician removed the stent and exchanged the wire, and then the lesion was pre-dilated with a 4mm balloon before attempting to cross the lesion again.A second attempt to cross the lesion also failed, and upon removal the stent started to deploy and elongated across a portion of the diseased sfa before fracturing.Therefore, a portion of the stent remained in the patient un-retrieved and a portion came out with catheter.Further intervention was performed where three additional innova stents (5mm x 120mm, 5mm x 100mm, 6mm x 150mm) were deployed to cover the un-retrieved fractured portion of the stent and lesion.Subsequently, the sfa was opened with blood flow through all stent.The procedure was completed successfully using an alternative method without sequela.

• Brand Name: INNOVA VASCULAR
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12986645
• Report Number: 2134265-2021-15522
• Device Sequence Number: 12198391
• Product Code: NIP
• UDI-Device Identifier: 08714729873952
• UDI-Public: 08714729873952
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2022

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 Expiration Date: 07/12/2026
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0027654474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 01/06/2022
• Initial Report FDA Received Date: 12/13/2021
• Supplement Report FDA Received Date: 01/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Sex: Female