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

Model Number	H74912044189070
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/03/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent inside the packaging was the incorrect size.A venous wallstent was selected for use in a venous stenting procedure to treat an 85mm long lesion in the left iliac vein.During the procedure, when the device was placed under fluoroscopy, it was noted that the stent was not the size labeled on the box.It was labeled 18mm x 90mm x 75cm on both the inner pouch and the outer carton.Radiographically, the device appeared to be an 18mm x 60mm stent mounted on an 18mm x 90mm delivery catheter.The stent was not deployed, and it was removed from the body.Another 18mm x 90mm x 75cm venous wallstent was deployed.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the venous wallstent was received for analysis.The device was returned with the stent fully mounted on the device.The stent was deployed without any issue.The stent measured approximately 60mm in length.A visual and tactile examination of the device tipidentified no issues with the tip of the device.A visual and tactile examination of the shaft identified no issues.No other issues were identified during the product analysis.Corrected h7: if remedial act init, type and if remedial act other, specify.
Event or Problem Description
It was reported that the stent inside the packaging was the incorrect size.A venous wallstent was selected for use in a venous stenting procedure to treat an 85mm long lesion in the left iliac vein.During the procedure, when the device was placed under fluoroscopy, it was noted that the stent was not the size labeled on the box.It was labeled 18mm x 90mm x 75cm on both the inner pouch and the outer carton.Radiographically, the device appeared to be an 18mm x 60mm stent mounted on an 18mm x 90mm delivery catheter.The stent was not deployed, and it was removed from the body.Another 18mm x 90mm x 75cm venous wallstent was deployed.The procedure was completed successfully.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: the venous wallstent was received for analysis.The device was returned with the stent fully mounted on the device.The stent was deployed without any issue.The stent measured approximately 60mm in length.A visual and tactile examination of the device tipidentified no issues with the tip of the device.A visual and tactile examination of the shaft identified no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent inside the packaging was the incorrect size.A venous wallstent was selected for use in a venous stenting procedure to treat an 85mm long lesion in the left iliac vein.During the procedure, when the device was placed under fluoroscopy, it was noted that the stent was not the size labeled on the box.It was labeled 18mm x 90mm x 75cm on both the inner pouch and the outer carton.Radiographically, the device appeared to be an 18mm x 60mm stent mounted on an 18mm x 90mm delivery catheter.The stent was not deployed, and it was removed from the body.Another 18mm x 90mm x 75cm venous wallstent was deployed.The procedure was completed successfully.No patient complications were reported.

• 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: 11887029
• Report Number: 2134265-2021-06818
• Device Sequence Number: 3399857
• Product Code: QAN
• UDI-Device Identifier: 08714729979616
• UDI-Public: 08714729979616
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P980033
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/18/2021

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: 12/16/2022
• Device Model Number: H74912044189070
• Device Catalogue Number: H74912044189070
• Device Lot Number: 0026527072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/03/2021
• Supplement Date Received by Manufacturer: 06/04/2021; 11/16/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 06/28/2021; 11/18/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male