MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER PFO OCCLUDER; CARDIAC OCCLUSION DEVICE

Device Problem Migration (4003)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Related manufacturer report number: 2135147-2019-00054, 2135147-2019-00062.In an article titled "device embolization in structural heart interventions incidence, outcomes, and retrieval techniques" on (b)(6) 2019, embolizations with the amplatzer family of devices including: amplatzer cardiac plug (acp), amplatzer amulet (acp2), amplatzer septal occluder (aso), amplatzer patent foramen ovale (pfo), amplatzer vascular plugs (avp), were discussed.The following excerpts were taken from the article that reference an abbott (formerly sjm device)."the amplatzer family of devices (acp and amulet, st.Jude medical, st.Paul, minnesota) appears to carry a higher risk of de compared with the watchman de- vice (boston scientific) (29 of 3,585 [0.78%] vs.19 of 7,236 [0.26%]; p < 0.001) (online table 1).However, de with the newer generation amplatzer device (amulet) was rare (0.2%) in a large multicenter registry of the 1,088 amulet implantations (29,30)"."early experience with the amplatzer septal occluder (st.Jude medical) (3,824 implants up to 2003) was associated with a 0.55% embolization rate.The majority of these were retrieved surgically (71.4%), and 2 were fatal (34).A similar rate was found in a query of the maude (manufacturer and user facility device experience) database, in which embolization of an amplatzer asd or pfo occluder was reported in 233 of 18,333 patients (0.62%) between january 2002 and june 2007 (35).Nonetheless, the rate of de appears to have decreased substantially overtime.In the closure of atrial septal defects with the amplatzer septal occluder post-approval study, de occurred only in 1 of 1,000 patients (0.1%) (36)"."embolization of amplatzer vascular plugs and/or other occluders is a rare complication of transcatheter closure of non-asd congenital or acquired defects (paravalvular leaks, pseudoaneurysms, fistula, and so on).For example, embolization of amplatzer vascular plugs occurred in 1% to 3.5% of cases in the largest series of trans- catheter paravalvular leak closure, but those embolizations were managed percutaneously in the vast majority of patients (53¿55)".Citations: (alkhouli m, sievert h, rihal cs.Device embolization in structural heart interventions: incidence, outcomes, and retrieval techniques.Jacc cardiovascular interventions.2019;12(2):113-126.Doi:10.1016/j.Jcin.2018.08.033.).

Manufacturer Narrative

An event of embolization was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8376576
• MDR Text Key: 137365882
• Report Number: 2135147-2019-00055
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/05/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 02/27/2019
• Supplement Dates Manufacturer Received: 03/13/2019
• Supplement Dates FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention