MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Catalog Number 9-ACP2-010-025

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/25/2023

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2023, a 25mm amplatzer amulet left atrial appendage occluder was selected for implant.The qa seal on the product box was intact.The physician tried to implant the device in the left atrial appendage (laa).The first position in the laa was quite ok, so the physician did a tuck-test.The device did not hold.The physician recaptured the device and saw a floating structure of the device.The physician took the occluder complete in the sheath.He decided to take a new occluder.The physician selected a 22mm amplatzer amulet left atrial appendage occluder that finished the procedure successfully.The activated clotting time (act) was over 250 seconds.The patient was stable.

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of a floating structure on the lobe of the device noted upon recapturing the device was reported.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Field indicated that the qa seal on the product box was intact and there was no damage noted to the product box or to the device itself during preparation.Information from the field also indicated that the patient did not have any hematological disorders that could contribute to a hypercoagulability and no medication was given post implant.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

Event Description

It was reported that on (b)(6) 2023, a 25mm amplatzer amulet left atrial appendage occluder was selected for implant.The qa seal on the product box was intact.The physician tried to implant the device in the left atrial appendage (laa).The first position in the laa was quite ok, so the physician did a tuck-test.The device did not hold.The physician recaptured the device and saw a floating structure on the lobe of the device which was wire in shape.The physician took the occluder complete in the sheath.He decided to take a new occluder.The physician selected a 22mm amplatzer amulet left atrial appendage occluder that finished the procedure successfully.The activated clotting time (act) was over 265 seconds and 100000 units of heparin was administered.The patient does not have hematologic disorders or systemic illness that could contribute to a hypercoagulability and no medication was given post implant.The patient was stable.

• Brand Name: AMPLATZER AMULET
• Type of Device: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17776271
• MDR Text Key: 323761215
• Report Number: 2135147-2023-04076
• Device Sequence Number: 1
• Product Code: NGV
• UDI-Device Identifier: 00811806013497
• UDI-Public: 00811806013497
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 8911352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2023
• 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 Sex: Male