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

Model Number	H74912044189070
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Mechanical Problem (1384); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was unable to be reconstrained.Vascular access was obtained via the jugular with a 11fr sheath.A 18x90x75cm venous wallstent was selected for a procedure in the non-thrombotic left iliac vein.The lesion had chronic diseased tissue, was mildly tortuous, and was approximately 56 percent stenosed.A 035 non-boston scientific guidewire easily crossed the ivus substantiated lesion.The wallstent was loaded over the same 035 guidewire and easily advanced through the lesion.Fifty percent of the stent deployed.An attempt was made to reconstrain the stent for the purpose of repositioning; however, the stent was unable to be reconstrained and 2cm of the stent was exposed.The sideport was re-flushed with no improvement.One centimeter of the stent was recaptured using pin-push maneuvers with greater force.The delivery shafts of the shaft deployment system became stuck and would not allow for either pin-pull deployment or pin-pull recapture.The stent was pulled back into the inferior vena cava (ivc) but was still unable to reconstrain the last 1 cm.The entire system was removed from the patient.The delivery shaft was compressed longitudinally in an accordian fashion.The procedure was completed with another of the same size wallstent.There were no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr: a venous wallstent was returned for analysis.The device was received with the stent partially deployed.A visual examination found no damage or issues with the partially deployed stent.A visual and tactile examination found the shaft of the device to have multiple shaft kinks and to have severe accordioned on the shaft approximately 160mm from the distal tip.A visual and tactile examination identified no issues with the tip of the device.
Event or Problem Description
It was reported that the stent was unable to be reconstrained.Vascular access was obtained via the jugular with a 11fr sheath.A 18x90x75cm venous wallstent was selected for a procedure in the non-thrombotic left iliac vein.The lesion had chronic diseased tissue, was mildly tortuous, and was approximately 56 percent stenosed.A 035 non-boston scientific guidewire easily crossed the ivus substantiated lesion.The wallstent was loaded over the same 035 guidewire and easily advanced through the lesion.Fifty percent of the stent deployed.An attempt was made to reconstrain the stent for the purpose of repositioning; however, the stent was unable to be reconstrained and 2cm of the stent was exposed.The sideport was re-flushed with no improvement.One centimeter of the stent was recaptured using pin-push maneuvers with greater force.The delivery shafts of the shaft deployment system became stuck and would not allow for either pin-pull deployment or pin-pull recapture.The stent was pulled back into the inferior vena cava (ivc) but was still unable to reconstrain the last 1 cm.The entire system was removed from the patient.The delivery shaft was compressed longitudinally in an accordian fashion.The procedure was completed with another of the same size wallstent.There were no patient complications.

• Brand Name: VENOUS WALLSTENT
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12822905
• Report Number: 2134265-2021-14403
• Device Sequence Number: 4787703
• Product Code: QAN
• UDI-Device Identifier: 08714729979616
• UDI-Public: 08714729979616
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P980033/S050
• 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): 12/13/2021

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: 08/20/2023
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Device Lot Number: 0027877683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/03/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 12/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 136 KG