MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number 9-ASD-028

Device Problems Migration or Expulsion of Device (1395); Off-Label Use (1494)

Patient Problems Myocardial Infarction (1969); Heart Failure/Congestive Heart Failure (4446)

Event Date 07/17/2023

Event Type  Death  

Event Description

It was reported that on (b)(6) 2023 a 28mm amplatzer septal occluder (lot: 8698480) was implanted utilizing a 10f amplatzer torqvue delivery system.The patient presented with a previous myocardial infarction resulting in a post infarction ventricular septal defect and a weak/unstable septal wall.Sizing was completed with tee and ct.The dimensions of the defect were 18mm x 21mm.Shortly after being released from the delivery cable, the device embolized to the right ventricle but did not cause obstruction.The device was attempted to be snared unsuccessfully.The patient then requested that no more attempts be made.The patient reportedly passed away on (b)(6) 2023.It was the physician's opinion that the weak septal wall was the cause of the embolization.There is no accusation of device performance in relation to the death.

Manufacturer Narrative

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

Manufacturer Narrative

An event of device embolization and patient death was reported.Information from the field indicated that the patient has a medical history of myocardial infarction, post-infarct ventricular septal defect (pivsd), kidney, and oxygen problems.The field also indicated that the sizing of the device was determined using the ct and tee.During the procedure, the device was embolized into the rv.The embolized device did not obstruct the blood flow.Based on the medical review " a patient with a post-infarct ventricular septal defect (pivsd) measuring 18mm x 21mm underwent a transcatheter pivsd closure using the 28mm amplatzer septal occluder (aso) off-label.Shortly after implant the device embolized into the right ventricle and multiple unsuccessful attempts were made to retrieve the device with a snare.The patient requested that all further attempts be stopped and subsequently passed away.Although the device embolized into the right ventricle it did not cause any obstruction.The most likely cause of death is patient-related due to the presence of an on-going left-to-right shunt across the pivsd.It is unclear why an implant attempt was made with the aso off-label rather than using the largest available pivsd occluder (size 24 mm).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 that the product met all specifications.Based on the information received the cause of the reporter device embolization was due to the weakened / unstable septal wall due to myocardial infarction, which is patient related not related to the device or the procedure.Please note, per the amplatzer septal occluder - instructions for use, "the amplatzer¿ septal occluder is a percutaneous, transcatheter atrial septal defect closure device intended for the occlusion of atrial septal defects (asds) in secundum position or patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration.Patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular (rv) volume overload (ie, 1.5:1 degree of left-to-right shunt or rv enlargement)."h6 health effect - clinical code: code 1969 removed.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: 17500003
• MDR Text Key: 320799210
• Report Number: 2135147-2023-03499
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010212
• UDI-Public: 00811806010212
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P000039
• 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: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-028
• Device Lot Number: 8698480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2022
• 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
• Treatment: 10F AMPLATZER TORQVUE DELIVERY SYSTEM
• Patient Outcome(s): Death