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

Model Number	26926
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
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 that the stent was partially deployed approximately 4mm from the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured location.Inspection of the remainder of the device, revealed no other damage or irregularities.The product analysis found damage that could have contributed to the inadvertent deployment.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 7 x 150 x 130 innova vascular stent self-expanding was selected for use.When the package was opened, the stent was partially deployed.The procedure was completed with another stent.No patient complications reported.
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 that the stent was partially deployed approximately 4mm from the middle sheath.There is a kink to the outer sheath at the nosecone.Microscopic examination revealed no additional damages.The lock and pull rack are still in the manufactured location.Inspection of the remainder of the device, revealed no other damage or irregularities.The product analysis found damage that could have contributed to the inadvertent deployment.
Event or Problem Description
It was reported that partial deployment occurred.A 7 x 150 x 130 innova vascular stent self-expanding was selected for use.When the package was opened, the stent was partially deployed.The procedure was completed with another stent.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: 20157942
• Report Number: 2124215-2024-55118
• Device Sequence Number: 4248716
• Product Code: NIP
• UDI-Device Identifier: 08714729874133
• UDI-Public: 08714729874133
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 09/06/2024

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 Expiration Date: 04/14/2026
• Device Model Number: 26926
• Device Catalogue Number: 26926
• Device Lot Number: 0027144656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/06/2024
• Initial Report FDA Received Date: 09/06/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/15/2021
• 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
• Patient Sex: Unknown