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

Model Number	26929
Medical Device Problem Codes	Premature Activation (1484); Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent deployment occurred.A 7 x 120 x 130 innova vascular self-expanding stent was selected for use in a peripheral stenting procedure to treat claudication.The 70% stenosed target lesion was located in the mildly calcified and non-tortuous left superficial femoral artery (sfa).Upon trying to cross the blockage in the left sfa and being unsuccessful, the stent was removed intact.However; it was noticed that the stent had migrated forward on the delivery system approximately 1/2cm.Therefore; the device was not used and a second device of the same size was implanted, and the procedure was successfully completed.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: 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 a kink to the sheath at the nosecone.The stent was partially deployed 5mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position.The middle sheath was still sitting on top of the proximal end of the tip.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 7 x 120 x 130 innova vascular self-expanding stent was selected for use in a peripheral stenting procedure to treat claudication.The 70% stenosed target lesion was located in the mildly calcified and non-tortuous left superficial femoral artery (sfa).Upon trying to cross the blockage in the left sfa and being unsuccessful, the stent was removed intact.However, it was noticed that the stent had migrated forward on the delivery system approximately 1/2cm.Therefore, the device was not used and a second device of the same size was implanted, and the procedure was successfully completed.No patient complications were reported.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 7 x 120 x 130 innova vascular self-expanding stent was selected for use in a peripheral stenting procedure to treat claudication.The 70% stenosed target lesion was located in the mildly calcified and non-tortuous left superficial femoral artery (sfa).Upon trying to cross the blockage in the left sfa and being unsuccessful, the stent was removed intact.However, it was noticed that the stent had migrated forward on the delivery system approximately 1/2cm.Therefore, the device was not used and a second device of the same size was implanted, and the procedure was successfully completed.No patient complications were reported.
Additional Manufacturer Narrative
Device eval by manufacturer: 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 a kink to the sheath at the nosecone.The stent was partially deployed 5mm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The thumbwheel lock and pull rack were still in the manufactured position.The middle sheath was still sitting on top of the proximal end of the tip.

• 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: 15302929
• Report Number: 2124215-2022-32434
• Device Sequence Number: 14774225
• Product Code: NIP
• UDI-Device Identifier: 08714729874126
• UDI-Public: 08714729874126
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 12/06/2023

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: 26929
• Device Catalogue Number: 26929
• Device Lot Number: 0028867520
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 09/14/2022; 11/17/2023
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 10/06/2022; 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/14/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown