MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER MUSCULAR VSD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-VSD-MUSC-016
Medical Device Problem Code	Material Perforation (2205)
Health Effect - Clinical Codes	Perforation (2001); Pericardial Effusion (3271)
Date of Event	07/17/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Further information regarding this event has been requested.The investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2019, a 16mm amplatzer muscular vsd occluder was selected for implant.The procedure was complex as the patient's defect was very apical.There was also the presence of a pseudo-aneurysm located on the lateral wall of the vd (ventricle defect) and a litany of trabeculations.As the physician was getting ready to deploy the device and a pericardial effusion on the lateral side of the vd was noted.The physician quickly deployed the occluder and punctured the pericardium.220cc of blood was extracted and after 125 minutes, a pericardial drain was set in place and the bleeding stopped.The procedure took longer than anticipated.The patient is reported to be in stable condition.Manufacturer report number: 2135147-2019-00224.
Additional Manufacturer Narrative
An event of pericardial effusion was reported.The results of the investigation are inconclusive since the device remains implanted 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 8865385
• Report Number: 2135147-2019-00223
• Device Sequence Number: 2883379
• Product Code: MLV
• UDI-Device Identifier: 00811806011844
• UDI-Public: 00811806011844
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 9-VSD-MUSC-016
• Device Catalogue Number: 9-VSD-MUSC-016
• Device Lot Number: 6056766
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/17/2019
• Supplement Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 9-ITV10F45/80, 7043953
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 86 YR
• Patient Weight: 66