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

Model Number	26924
Medical Device Problem Codes	Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a partial deployment occurred.An 8 x 60 x 130 innova was selected for deployment.During the procedure, when the device was stent to deploy, the rotating mechanism that signifies full deployment kept spinning.The physician believed that the device was fully deployed but when the device was withdrawn, it was identified that the stent got caught on the sheath when taken out.No further information was reported to boston scientific regarding the procedure or patient status.
Additional Manufacturer Narrative
Device evaluated by mfr.: innova self-expanding stent system was returned with part of an unknown sheath.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.The pull rack is separated at the handle and the proximal section did not return for analysis.Microscopic examination revealed no additional damages.The stent appears to be stuck inside the unknown sheath, so it was x-rayed.X-ray of the sheath shows that the stent is stretched and separated.The separated section of the stent did not return for analysis.Because there was no evidence of any product quality deficiencies, it was considered likely that the kink was attributable to handling when the device was sent back for analysis.There were no other damage or irregularities found in the remainder of the device.D4: lot number: corrected from 0028604985 to 0028309652 d4: expiration date: corrected from 12/22/2026 to 11/01/2026 h4: device manufacture date: corrected from 12/23/2021 to 11/02/2021.
Event or Problem Description
It was reported that a partial deployment occurred.An 8 x 60 x 130 innova was selected for deployment.During the procedure, when the device was stent to deploy, the rotating mechanism that signifies full deployment kept spinning.The physician believed that the device was fully deployed but when the device was withdrawn, it was identified that the stent got caught on the sheath when taken out.No further information was reported to boston scientific regarding the procedure or patient status.

• 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: 19045244
• Report Number: 2124215-2024-19004
• Device Sequence Number: 7308245
• Product Code: NIP
• UDI-Device Identifier: 08714729874188
• UDI-Public: 08714729874188
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/07/2024

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: 26924
• Device Catalogue Number: 26924
• Device Lot Number: 0028309652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/08/2024
• Supplement Date Received by Manufacturer: 04/09/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2021
• 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