MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION VENOUS WALLSTENT; STENT, ILIAC VEIN

Model Number	H74912044189070
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck on the wire.A 18x90x75cm venous wallstent was selected for a patient left leg venogram procedure to treat poor venous return.The lesion was mildly calcified and mildly tortuous.The device was implanted, and then upon withdrawal/closure the device became stuck on the wire.The wire and the stent delivery system were removed as a unit.The devices were removed from the patient intact.Once outside the patient, the physician wiggled, moved, and adjusted the catheter until it finally came unstuck and was able to be removed.The procedure was completed successfully.
Additional Manufacturer Narrative
Device eval by manufacturer: the device was received inserted in a introducer sheath.No issues were noted with the stent cups or stent holder.The device was received with the stent deployed from the delivery system.The deployed stent was not returned.A visual and tactile examination found a shaft kink 245mm distal from the distal end of the t connector.The guidewire was unable to be inserted due to the shaft kink.A visual and tactile examination identified no issues with the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the device became stuck on the wire.A 18x90x75cm venous wallstent was selected for a patient left leg venogram procedure to treat poor venous return.The lesion was mildly calcified and mildly tortuous.The device was implanted, and then upon withdrawal/closure the device became stuck on the wire.The wire and the stent delivery system were removed as a unit.The devices were removed from the patient intact.Once outside the patient, the physician wiggled, moved, and adjusted the catheter until it finally came unstuck and was able to be removed.The procedure was completed successfully.

• Brand Name: VENOUS WALLSTENT
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12160338
• Report Number: 2134265-2021-08834
• Device Sequence Number: 11942887
• Product Code: QAN
• UDI-Device Identifier: 08714729979616
• UDI-Public: 08714729979616
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2021

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: 04/28/2023
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Device Lot Number: 0027219309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/22/2021
• Supplement Date Received by Manufacturer: 08/05/2021
• Initial Report FDA Received Date: 07/13/2021
• Supplement Report FDA Received Date: 08/25/2021
• Patient Sequence Number: 1