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

Model Number	26927
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed and stretched.A 6 x 200 x 130 innova self expanding stent was selected for use in a stenting procedure.A contralateral approach was used to access the 90% stenosed superficial femoral artery that was severely calcified and severely tortuous.The lesion was pre-dilated with a 5 x 220 sterling balloon.During deployment of the innova device, the stent would not fully deploy.Elevated force was required to turn the thumbwheel and then it stopped working.Only 60% of the stent was deployed.The pull grip was pulled in an attempt to deploy the last 100mm.Some of the stent deployed, but not all of it.The blue handle was pulled harder, and the stent eventually deployed but elongated.The stent stretched approximately 20mm.After implanting the stent, the delivery system became stuck on the 018 non-boston scientific guidewire.The handle was disassembled in order to pull it off the guidewire, but this was unsuccessful.External to the patient, the physician then used a scalpel to cut away the proximal section of the delivery system to expose the guidewire and pull the distal part of the delivery system off the guidewire.The implanted stent was fully expanded and post dilated.The procedure was successfully completed.No patient complications were reported.
Event or Problem Description
It was reported that the stent partially deployed and stretched.A 6 x 200 x 130 innova self expanding stent was selected for use in a stenting procedure.A contralateral approach was used to access the 90% stenosed superficial femoral artery that was severely calcified and severely tortuous.The lesion was pre-dilated with a 5 x 220 sterling balloon.During deployment of the innova device, the stent would not fully deploy.Elevated force was required to turn the thumbwheel and then it stopped working.Only 60% of the stent was deployed.The pull grip was pulled in an attempt to deploy the last 100mm.Some of the stent deployed, but not all of it.The blue handle was pulled harder, and the stent eventually deployed but elongated.The stent stretched approximately 20mm.After implanting the stent, the delivery system became stuck on the 018 non-boston scientific guidewire.The handle was disassembled in order to pull it off the guidewire, but this was unsuccessful.External to the patient, the physician then used a scalpel to cut away the proximal section of the delivery system to expose the guidewire and pull the distal part of the delivery system off the guidewire.The implanted stent was fully expanded and post dilated.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 that the handle was partially open.There was multiple buckling to the outer sheath.There were multiple kinks along the outer sheath.The proximal inner was prolapsed.There were multiple kinks along the proximal inner.The middle sheath was separated 97.5cm from the distal end of the middle sheath.The outer sheath was separated 3.5cm from the nosecone.The proximal inner was separated 77.1cm from the distal end.Microscopic examination revealed no additional damages.Inspection of the remainder of the device revealed no other damage or irregularities.Product analysis found damage that would have contributed to the deployment issue, stent deformation, difficulty removing, and guidewire entrapment.

• 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: 17907391
• Report Number: 2124215-2023-56084
• Device Sequence Number: 8224742
• Product Code: NIP
• UDI-Device Identifier: 08714729874065
• UDI-Public: 08714729874065
• 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
• Device Implanted Year: 2023
• 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): 11/09/2023

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: 09/15/2025
• Device Model Number: 26927
• Device Catalogue Number: 26927
• Device Lot Number: 0030163411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/18/2023
• Supplement Date Received by Manufacturer: 10/25/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/16/2022
• 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: 018 TERUMO GLIDEWIRE ADVANTAGE; 018 TERUMO GLIDEWIRE ADVANTAGE
• Patient Sex: Unknown