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

Model Number	9-AVP2-016
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	Pain (1994)
Date of Event	06/19/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2025, a 16mm amplatzer vascular plug ii was chosen for iliac embolization using a 6f non-abbott sheath.During procedure, using a non-abbott catheter and non-abbott wire, the sheath was advanced over the aortic bifurcation into the left common iliac artery and digital subtraction angiography (dsa) was performed.Dsa demonstrated a 3.5 x 4.6cminternal iliac aneurysm with an 11.6cm neck.The 16mm amplatzer plug was advanced into the aneurysm, followed by sheath retraction with the proximal end of the plugin the satisfactory position within the aneurysm neck.Despite prolonged attempts, the plug would not deploy using the unscrewing mechanism.Attempts to retract the plug into the sheath then resulted in buckling of the sheath, with the distal portion of the plug stuck external to the tip of the sheath.The patient developed pain and a moderate sized hematoma in the right groin at the femoral artery access site with the sheath still in situ.There was arterial bleeding spurting from the sheath entry site, controlled by manual compression.It was clear that there was no further endovascular option for removal of the plug.The patient was transferred to theatre to open the site and to retrieve the plug with sheath.The patient remained hemodynamically stable throughout the procedure.The patient was reported discharged.
Additional Manufacturer Narrative
An event of pain, and difficulty releasing device from cable when implanted was reported.It was also reported that there was difficulty retracting the device into the sheath.The device was returned to abbott for investigation and the device met dimensional specifications when analyzed under non-physiological conditions.No issues were found with the screw of the plug when tested per drawing specifications.Delivery cable was noted to be bent and a non-abbott device was returned with the plug.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There were no complaints associated with any other devices from the lot.The reported pain appeared to be related to the plug shut into the sheath.The reported unexpected surgical intervention was a result of case-specific circumstances as the plug was surgically removed.Based on the information received, the cause of the reported separation problem could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note that per the instruction for use (ifu), the recommended delivery sheath size for a 16 mm amplatzer vascular plug ii is 8f delivery sheath.Additionally, the imaging provided by the account were further reviewed by an abbott staff.The reviewer noted that "4 jpgs of procedural fluoro were provided.First 2 images (7773 and 7774) show traversing vasculature to aneurysm and angiogram of the aneurysm.3rd image (7775) shows packing the aneurysm with coil.Img 7776 shows other angiogram of the neck of the aneurysm and plug is not identifiable.2 jpgs are of description of procedure write up.".
Event or Problem Description
N/a.
Event or Problem Description
N/a.
Additional Manufacturer Narrative
It was reported that there was separation failure and difficulty retracting the device into the sheath.The 16 mm avp 2 plug was returned to abbott and examined.The returned delivery cable was noted to be bent.A non-abbott delivery system was returned and appeared to be damaged.The plug was able to be connected and detached from the returned delivery cable without any difficulty when analyzed under non-physiological conditions.Additionally, the end screw of the plug met abbott drawing specifications.Please note that per the amplatzer ¿ vascular plug ii instructions for use, delivery sheath size with an inner diameter of =2.18 mm =2.69 mm is recommended for use with a 16 mm plug.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.There were no complaints associated with any other devices from the lot.The reported patient effect of pain appears to be related to procedural difficulties.The surgical intervention was a result of case-specific circumstances to retrieve the plug with sheath.Based on the investigation findings and cine review performed at abbott, the cause of the reported separation failure could not be conclusively determined.The cause of retraction problem could not be determined as a non-abbott delivery system was used and returned in damaged state.

• Brand Name: AMPLATZER VASCULAR PLUG II
• 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: 22533041
• Report Number: 2135147-2025-03890
• Device Sequence Number: 18097571
• Product Code: KRD
• UDI-Device Identifier: 00811806010410
• UDI-Public: (01)00811806010410(17)290630(10)10440417
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K071699
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 11/03/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-AVP2-016
• Device Catalogue Number: 9-AVP2-016
• Device Lot Number: 10440417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2025
• Supplement Date Received by Manufacturer: 09/11/2025; 10/09/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 09/23/2025; 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2024
• 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