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

Model Number	9-VSD-MUSC-014
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/30/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, a 12mm amplatzer muscular vsd occluder was not implanted due to sizing.The device was exchanged for a 14mm amplatzer muscular vsd occluder (lot number: 5008417).After releasing the occluder, the device embolized to the patient's lung and the patient was reintubated and the device was retrieved.A 12-10mm amplatzer duct occluder (lot number: 479522) was selected for implant, however it was removed prior to release due to sizing.An 18mm amplatzer muscular vsd occluder (lot number: 4959869) was selected for implant, but it was also removed prior to release due to sizing.And a 22/18mm amplatzer vascular plug ii (lot number: 5335493) was selected for implant, however, it was not released due to sizing.There were no patient consequences reported and surgical closure will be scheduled on a later date.
Additional Manufacturer Narrative
An event of embolization was reported.The investigation confirmed the occluder met functional and dimensional specifications when analyzed at abbott.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The cause of the reported event remains unknown.
Event or Problem Description
On (b)(6) 2018, a pda type c had measurements of 23.3mm aortic ampulla, 9.7mm at its narrowest, and 19mm long.A 12mm amplatzer muscular vsd occluder was selected but was not implanted due to sizing.The device was exchanged for a 14mm amplatzer muscular vsd occluder (lot number: 5008417).The 14mm vsd occluder was deployed and released.The patient was extubated and fluoroscopy revealed the device embolized to the patient's right pulmonary artery.The patient was reintubated and the device was retrieved via snare.A 12-10mm amplatzer duct occluder (lot number: 4799522) was selected for implant, however it was removed prior to release due to rigidity and length not being appropriate.An 18mm amplatzer muscular vsd occluder (lot number: 4959869) was selected for implant, but it was also removed prior to release due to sizing.And a 22/18mm amplatzer vascular plug ii (lot number: 5335493) was selected for implant, however, it was not released due to sizing.There were no patient consequences reported and surgical closure will be scheduled on a later date.

• Brand Name: AMPLATZER MUSCULAR VSD OCCLUDER
• Common Device Name: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 7901802
• Report Number: 2135147-2018-00160
• Device Sequence Number: 169389
• Product Code: MLV
• UDI-Device Identifier: 00811806011837
• UDI-Public: 00811806011837
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/31/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 9-VSD-MUSC-014
• Device Catalogue Number: 9-VSD-MUSC-014
• Device Lot Number: 5008417
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/04/2018
• Supplement Date Received by Manufacturer: 09/04/2018; 10/17/2018
• Initial Report FDA Received Date: 09/24/2018
• Supplement Report FDA Received Date: 10/04/2018; 10/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 76