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

Catalog Number 9-ACP2-010-028

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 10/27/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on 27 october 2023, a 25mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During procedure, the patient's activated clotting time (act) levels was between 265-300 seconds and heparin was administered.After three partial recaptures, it was noted that the device was too small, leaving a jet beside the device.There was no additional product experience other than the mis-sizing and the device was removed from the patient prior to release.It was decided to change the device and a new 28mm amplatzer amulet left atrial appendage occluder was chosen using the same 14f amplatzer torqvue 45x45 delivery sheath.After two partial recaptures the device was fully recaptured and removed.While preparing the a new 22mm amplatzer amulet left atrial appendage occluder, the echocardiogram (echo) sonographer noticed a pericardial effusion in the left atrial appendage and drop in blood pressure.Two dose of pressers were given.And a pericardiocentesis was performed and over 1000cc of blood was drained.The physician mentioned the cause of effusion was the 28mm amulet.The patient required open heart surgery.The 28mm amulet was removed from the patient.The 22mm amulet was not used in the patient.The patient was reported as stable.

Event Description

It was reported that on 27 october 2023, a 25mm amplatzer amulet left atrial appendage occluder was chosen for implant using a 14f amplatzer torqvue 45x45 delivery sheath.During procedure, the patient's activated clotting time (act) levels was between 265-300 seconds and heparin was administered.After three partial recaptures, it was noted that the device was too small, leaving a jet beside the device.There was no additional product experience other than the mis-sizing and the device was removed from the patient prior to release.It was decided to change the device and a new 28mm amplatzer amulet left atrial appendage occluder was chosen using the same 14f amplatzer torqvue 45x45 delivery sheath.After two partial recaptures the device was fully recaptured and removed from the patient prior to release.While preparing the a new 22mm amplatzer amulet left atrial appendage occluder, the echocardiogram (echo) sonographer noticed a pericardial effusion in the left atrial appendage and drop in blood pressure.The physician mentioned the cause of effusion was the 28mm amulet.Two dose of pressers were given.And a pericardiocentesis was performed and over 1000cc of blood was drained.After the pericardiocentesis the bleeding was not stopped and the patient required open heart surgery.The 22mm amulet was not used in the patient.The patient was reported as stable.No additional information was provided.

Manufacturer Narrative

An event of pericardial effusion and low blood pressure/hypotension were 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note that per the instruction for use, amplatzer¿ amulet¿ left atrial appendage occluder, stated "warnings:¿ if the device is retracted while it is in the sheath, the device and the sheath must both be removed and replaced.Failure to replace both the device and the sheath may result in sheath and/or device malfunction.Note: do not oversize or undersize the delivery sheath.Follow the recommended sizes listed in table t1.".

• 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: 18183904
• MDR Text Key: 328692665
• Report Number: 2135147-2023-05121
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-010-028
• Device Lot Number: 8795525
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2022
• 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
• Patient Age: 79 YR
• Patient Sex: Female