MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG 4; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	VASCULAR PLUG 4
Medical Device Problem Codes	Difficult to Fold, Unfold or Collapse (1254); Fracture (1260); Improper or Incorrect Procedure or Method (2017); Separation Problem (4043)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Insufficient Information (4580)
Date of Event	05/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2023, a 6mm amplatzer vascular plug iv was selected for an implant.During the procedure, there was issue with the plug.It was impossible to detach the plug and impossible to retrieve the plug after deployment in the left gonadal vein.The pusher was left in place (left gonadal vein, left renal vein, left cave vein, right iliac vein and right common femoral vein) and secured in the right iliac vein with a stent to limit risk of secondary migration.An antiaggregant treatment will be applied to the patient for 6 months post procedure to limit the risk of venous thrombosis at the renal vein, risk of complication at the lower member, risk of migration in the heart.The procedure time was extended to a total time of 3 hours.Patient status was reported as stable.
Additional Manufacturer Narrative
An event of the plug being unable to be released from the cable was reported.The delivery cable was received for examination which found that the plug was no longer attached to the endscrew of the delivery cable, but that the outer coil of the cable was unraveled and detached from the end of the endscrew.No other damage was noted to the cable or endscrew.The device was sent for further examination using sem.The end of the coil was examined with no indication of a fracture being found along the length.Information from the field indicated that the end of the coil was cut and left in the patient.The endscrew, where the coil is welded to the inner cable, was examined and there appeared to be minimal indication of a metallurgical bond at this surface, with minimal fracture features being present.It was reported the outer coil became unraveled during attempts to detach the plug.It is possible the outer coil caught on the plug after the weld fractured and the coil unraveled, resulting in the end of the coil being unable to be removed from the patient after the plug detached from the endscrew.Abbott has initiated additional investigation as a result of this finding.H6 health effect - clinical code: code 4580 removed.
Event or Problem Description
It was reported that on (b)(6) 2023, a 6mm amplatzer vascular plug iv was selected for an implant.During the procedure, there was issue with the plug.It was impossible to detach the plug and impossible to retract the plug after deployment in the left gonadal vein.The delivery wire was left in place (left gonadal vein, left renal vein, left cave vein, right iliac vein and right common femoral vein) and secured in the right iliac vein with a stent to limit risk of secondary migration.The patient did not have a tortuous anatomy.The plug was not deformed/damaged/ during procedure.An antiaggregant treatment will be applied to the patient for 6 months post procedure to limit the risk of venous thrombosis at the renal vein, risk of complication at the lower member, risk of migration in the heart.The procedure time was extended to a total time of 3 hours.Patient status was reported as stable.No additional information provided.On 18 august 2023, additional information received; the plug remained implanted at the target lesion and remained attached to the distal part of the cable.Part of the cable with the plug and left in the patient.The cable is maintained by the plug distally and by the stent implanted in the right iliac vein in order to maintain as much as possible the cable and to prevent any migration.
Additional Manufacturer Narrative
An event of the plug being unable to be released from the cable was reported.The delivery cable was received for examination which found that the plug was no longer attached to the endscrew of the delivery cable, but that the outer coil of the cable was unraveled and detached from the end of the endscrew.No other damage was noted to the cable or endscrew.The device was sent for further examination using sem.The end of the coil was examined with no indication of a fracture being found along the length.Information from the field indicated that the end of the coil was cut and left in the patient.The endscrew, where the coil is welded to the inner cable, was examined and there appeared to be minimal indication of a metallurgical bond at this surface, with minimal fracture features being present.It was reported the outer coil became unraveled during attempts to detach the plug.It is possible the outer coil caught on the plug after the weld fractured and the coil unraveled, resulting in the end of the coil being unable to be removed from the patient after the plug detached from the endscrew.Abbott has initiated additional investigation as a result of this finding.

• Brand Name: AMPLATZER VASCULAR PLUG 4
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17148744
• Report Number: 2135147-2023-02634
• Device Sequence Number: 12205441
• Product Code: KRD
• UDI-Device Identifier: 00811806012360
• UDI-Public: 00811806012360
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VASCULAR PLUG 4
• Device Catalogue Number: 9-AVP038-006
• Device Lot Number: 8700790
• 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: 05/24/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 12/08/2023
• Initial Report FDA Received Date: 06/16/2023
• Supplement Report FDA Received Date: 11/10/2023; 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown