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

Model Number 9-ASD-030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Pericardial Effusion (3271)

Event Date 08/24/2018

Event Type  Death  

Manufacturer Narrative

An event of cardiac perforation, effusion and patient death was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

This case was a "surgical turn down" due to the condition of the patient.During a procedure to close a post infarct ventricular septal defect (vsd), the defect was crossed using the standard method left to right technique to create an av loop.The device access was via transjugular approach.The 12f torqvue 45 delivery system (dtv45) was introduced and crossed through the defect to the right ventricle and then to the left ventricle over the guidewire.A 24 mm amplatzer p.I.Muscular vsd occluder (pimuscvsd) (lot: 6351799) was selected and deployed in an inferior apical defect.The left ventricular disc prolapsed through the defect without applying tension as the defect was large so the pimuscvsd device was removed and a 30 mm amplatzer septal occluder (aso) was then attempted to be used off-label.The dtv45 sheath was still in the right ventricle, however; the guidewire was no longer across the defect due to breaking the circuit to allow deployment of the 24 mm pimuscvsd.The user decided that due to the size of the defect they would try and cross from the right ventricle to the left ventricle using a pigtail catheter and guidewire.The defect was crossed and the pigtail catheter was positioned in the aorta for stability.The echo cardiologist noticed that the dtv45 sheath had crossed the defect.The angle was different to the first position (sitting at the apex of the ventricle) and there was concern the user had gone through another defect, so sometime was spent checking the position of the dtv45 to confirm it was through the same defect.The left disc of the 30 mm aso was deployed in the right ventricle, but at this time an effusion was noted on echocardiogram by the cardiologist.The aso was fully recaptured and the 12f amplatzer torqvue 45 delivery system was pulled back into the right side of the heart.The effusion was noted to have been caused by rupture of the free wall and the patient died during the procedure.The cause of the rupture of the free wall is unknown.

Event Description

This case was a "surgical turn down" due to the condition of the patient.During a procedure to close a post infarct ventricular septal defect (vsd), the defect was crossed using the standard method left to right technique to create an av loop.The device access was via transjugular approach.The 12f torqvue 45 delivery system (dtv45) was introduced and crossed through the defect to the right ventricle and then to the left ventricle over the guidewire.A 24 mm amplatzer p.I.Muscular vsd occluder ((b)(4)) (lot: 6351799) was selected and deployed in an inferior apical defect.The left ventricular disc prolapsed through the defect without applying tension as the defect was large so the (b)(4) device was removed and a 30 mm amplatzer septal occluder (aso) was then attempted to be used off-label.The dtv45 sheath was still in the right ventricle, however; the guidewire was no longer across the defect due to breaking the circuit to allow deployment of the 24mm (b)(4).The user decided that due to the size of the defect they would try and cross from the right ventricle to the left ventricle using a pigtail catheter and guidewire.The defect was crossed and the pigtail catheter was positioned in the aorta for stability.The echo cardiologist noticed that the dtv45 sheath had crossed the defect.The angle was different to the first position (sitting at the apex of the ventricle) and there was concern the user had gone through another defect, so sometime was spent checking the position of the dtv45 to confirm it was through the same defect.The left disc of the 30mm aso was deployed in the left ventricle, but at this time an effusion was noted on echocardiogram by the cardiologist.The aso was fully recaptured and the 12f amplatzer torqvue 45 delivery system was pulled back into the right side of the heart.The effusion was noted to have been caused by rupture of the free wall and the patient died during the procedure.The cause of the rupture of the free wall is unknown.Medical records, including echocardiogram reports, were requested from the hospital but have not been made available.

• Brand Name: AMPLATZER SEPTAL 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: 7863934
• MDR Text Key: 119802724
• Report Number: 2135147-2018-00148
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010229
• UDI-Public: 00811806010229
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/24/2018

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
• Device Expiration Date: 10/31/2022
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 6211429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 09/19/2018
• Supplement Dates FDA Received: 09/24/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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; Hospitalization; Required Intervention