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

Model Number	26924
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed during device preparation.An innova 6 x 40 x 130 was selected for use to treat the patients right superficial femoral artery (sfa) stenosis.During device preparation, the stent partially deployed prior to entering the patient.The device was replaced with another innova 6 x 40 x 130 in order to complete the procedure.There were no adverse consequences to the patient reported.
Additional Manufacturer Narrative
Device media analysis: 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 stent was missing.There was a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack were still in the manufactured location but the middle sheath was no longer sitting on top of the proximal end of the tip.Inspection of the remainder of the device, revealed no other damage or irregularities.Product analysis found damage that could have contributed to the partial deployment.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 16375825
• Report Number: 2124215-2023-06698
• Device Sequence Number: 17573193
• Product Code: NIP
• UDI-Device Identifier: 08714729873990
• UDI-Public: 08714729873990
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 02/14/2023

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: 0028675898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/25/2023
• Initial Report FDA Received Date: 02/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INNOVA 6 X 40 X 130 IN.
• Patient Age: 72 YR
• Patient Sex: Male