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

Catalog Number 9-ASD-009

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problems Hemolysis (1886); Hemorrhage/Bleeding (1888); Hemothorax (1896); Hypoxia (1918); Thrombosis/Thrombus (4440); Respiratory Insufficiency (4462)

Event Date 11/01/2023

Event Type  Death  

Event Description

Clinical information: (b)(6).Patient site id: (b)(6).It was reported that on (b)(6) 2023, a 9mm amplatzer septal occluder was successful implanted in patient.Amplatzer septal occluder (lot number: 8565272) was implanted for perivalvular but did not completely close perivalvular leakage (pvl).An additional two amplatzer septal occluders (lot number: 8528784 and 7712146) were implanted for closure of pvl.Two amplatzer vascular plugs 2 (lot number: 8813477) and (serial number: unknown) were released during procedure, but were percutaneously removed for unknown reason.Two amplatzer valvular plugs 3 (9-apvl3ide-105, serial number: (b)(6)) and (9-apvl3ide-145, serial number: (b)(6)) were attempted for implant, but were percutaneously removed prior to release from the delivery cable.Only one non-abbott was used throughout the whole procedure.Post-implant it was noted that the patient had a residual shunt that resulted in hemolysis and hemoglobinuria.The decision was made to implant an unknown size amplatzer vascular plug 2 using a trans-septal approach.On (b)(6) 2023, it was noted that the patient developed a left hemothorax with an apical left ventricle bleed from the transapical repair of the patient's mitral valve perivalvular leak.The decision was made to place a drainage.It was also noted that the patient passed away on an unknown date due to an unknown cause.

Manufacturer Narrative

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

Manufacturer Narrative

An event of thrombus, residual shunt, and off-label use 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.Information from the field indicated that a closure of a perivalvular leak (pvl) from epic valve was attempted.Initially, two amplatzer valvular plug 3 were attempted for implant, but they could not be deployed in a stable configuration due to being excessively small, and were removed.There was no other issue with the amplatzer valvular plugs 3 other than mis-sizing.Then, two amplatzer vascular plug 2 were attempted for the pvl closure and both were deployed.However, they were not stable and embolized into the patient's abdominal aorta.They were retrieved with a snare.Then, amplatzer septal occluders were implanted for the pvl.Additionally, it was noted that there was significant hemolysis and the patient returned for implant of an additional amplatzer vascular plug 2.It was noted that the amplatzer vascular plug 2 was implanted using a trans-septal approach, after a failed trans-apical approach.It also noted that the patient had begun to suffer from respiratory distress and hypoxia.The patient was noted to have hemothorax with left ventricular thrombosis and bleeding that was drained.The patient also underwent atrial septal defect closure with a 10mm amplatzer vascular plug 2 , a left anterior thoracotomy, and was transfused.Later on, the patient passed away and the cause of death is believed to be related to cardiac surgery and left ventricular thrombosis.The cause of left ventricular thrombosis is attributed to complication of surgery.Prior to the implant procedure, the patient had class iv heart failure and cardiac cachexia.Based on the information received, a root cause of the reported events appeared to be related procedure conditions and patient conditions.A reported off-label use related to the user used amplatzer septal occluder for perivalvular leak.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Per the instructions for use, amplatzer septal occluder, stated "indications: the amplatzer¿ septal occluder is indicated for patients with ostium secundum atrial septal defect or fenestrations." this is considered as an off-label use of the device.However, it was unable to determine if the off-label use contributed to the reported incident.In addition, the implanting physician was aware the amplatzer septal occluder ifu indications.Therefore, a letter will not be sent out to the accountant.

Event Description

Clinical information: (b)(6).It was reported that on (b)(6) 2023, a 9mm amplatzer septal occluder was successful implanted in patient.Amplatzer septal occluder (lot number: 8565272) was implanted for perivalvular but did not completely close perivalvular leakage (pvl).An additional two amplatzer septal occluders (lot number: 8528784 and 7712146) were implanted for closure of pvl.Two amplatzer vascular plugs 2 (lot number: 8813477) and (serial number: unknown) were released during procedure, but were percutaneously removed for unknown reason.Two amplatzer valvular plugs 3 (9-apvl3ide-105, serial number: (b)(6)) and (9-apvl3ide-145, serial number: (b)(6)) were attempted for implant, but were percutaneously removed prior to release from the delivery cable.Only one non-abbott was used throughout the whole procedure.Post-implant it was noted that the patient had a residual shunt that resulted in hemolysis and hemoglobinuria.The decision was made to implant an unknown size amplatzer vascular plug 2 using a trans-septal approach, after a failed trans-apical approach.On (b)(6) 2023, it was noted that the patient developed a left hemothorax with an apical left ventricle bleed from the transapical repair of the patient's mitral valve perivalvular leak.The decision was made to place a drainage.It was also noted that the patient passed away on an unknown date due to an unknown cause.No additional information was provided.--final emdr-- subsequent to the previously filed report, additional information was received that the sequence of events for the use of each device is as follows.A closure of a perivalvular leak (pvl) from 31mm epic valve was attempted.Initially, two amplatzer valvular plug 3 were attempted for implant, but they could not be deployed in a stable configuration due to being excessively small, and were removed without detaching them from the delivery cable.There was no other issue with the amplatzer valvular plugs 3 other than mis-sizing.Next, two amplatzer vascular plug 2 were attempted for the pvl closure, both were deployed, but were not stable and embolized into the patient's abdominal aorta.The two embolized amplatzer vascular plug 2 were snared.After successful removal of the plugs, the decision was made to implant three amplatzer septal occluders for complete closure of the perivalvular leak.On (b)(6) 2023, it was noted that there was significant hemolysis and the patient returned for implant of an additional amplatzer vascular plug 2.It was noted that the amplatzer vascular plug 2 was implanted using a trans-septal approach, after a failed trans-apical approach.It also noted that the patient had begun to suffer from respiratory distress and hypoxia.The patient was noted to have hemothorax with left ventricular thrombosis and bleeding that was drained.The patient also underwent atrial septal defect closure with a 10mm amplatzer vascular plug 2 , a left anterior thoracotomy, and was transfused.The patient passed away on (b)(6) 2023, the cause of death is believed to be related to cardiac surgery and left ventricular thrombosis.The cause of left ventricular thrombosis is attributed to complication of surgery.

• 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: 18220643
• MDR Text Key: 329158853
• Report Number: 2135147-2023-05223
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010069
• UDI-Public: (01)00811806010069(17)250930(10)7712146
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-ASD-009
• Device Lot Number: 7712146
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/23/2020
• 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): Death