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

Model Number	H74939293054030
Medical Device Problem Codes	Premature Activation (1484); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.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.Microscopic examination revealed no additional damages.The stent is outside of the sheath.The sheath is no longer in the manufactured position while the lock and pull rack are still in the manufactured position.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.
Event or Problem Description
It was reported that premature deployment occurred.The 70% stenosed target lesion was located in the moderately tortuous and moderately calcified artery.A 5 x 40 x 130 innova vascular stent was selected for use.During the procedure, the innova was advanced onto the 035 boston scientific guidewire.A slight bend was observed at the back end of the guidewire.Resistance was encountered while advancing into the sheath.Upon reaching approximately 5 cm from the target lesion, it was noted that the stent had begun deploying prematurely, despite the yellow safety mechanism remaining intact.Upon removal from the sheath, the stent was found to have fully deployed onto the delivery shaft and was successfully removed from the body.The delivery system appeared to be fully intact.An additional innova of the same size was used to complete the procedure.There were no patient complications 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: 20834670
• Report Number: 2124215-2024-74975
• Device Sequence Number: 8627983
• Product Code: NIP
• UDI-Device Identifier: 08714729873907
• UDI-Public: 08714729873907
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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
• Report Date (Section B): 12/03/2024

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: H74939293054030
• Device Catalogue Number: H74939293054030
• Device Lot Number: 0032642492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/16/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: BALLOON - COYOTE; SHEATH USED - CATAPULT
• Patient Sex: Unknown