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

Model Number	26929
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	06/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inadvertently deployed.This 5 x 120 x 130 innova vascular stent was selected for use in a distal superficial femoral artery stenting procedure.During preparation, upon opening the packaging it was noted that the sheath covering the stent was partially pulled back from the stent; thereby inadvertently deploying the stent.The yellow protective safety clip remained in place and the thumbwheel was not touched.The procedure was completed with another of the same device.There were no patient complications.
Event or Problem Description
It was reported that the stent inadvertently deployed.This 5 x 120 x 130 innova vascular stent was selected for use in a distal superficial femoral artery stenting procedure.During preparation, upon opening the packaging it was noted that the sheath covering the stent was partially pulled back from the stent; thereby inadvertently deploying the stent.The yellow protective safety clip remained in place and the thumbwheel was not touched.The procedure was completed with another of the same device.There were no patient complications.
Additional Manufacturer Narrative
Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this 5 x 120 x 130 innova vascular stent system was inspected for damage.Visual examination revealed that the stent was partially deployed approximately 1cm from the middle sheath.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 inadvertent deployment.

• 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: 17170238
• Report Number: 2124215-2023-32039
• Device Sequence Number: 7201139
• Product Code: NIP
• UDI-Device Identifier: 08714729873945
• UDI-Public: 08714729873945
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 07/24/2023

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 Expiration Date: 04/22/2026
• Device Model Number: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0027192373
• 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: 06/16/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 06/21/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown