MAUDE Adverse Event Report: ST. JUDE MEDICAL, COSTA RICA LTDA AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number	9-ASD-012
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Death (1802)
Date of Event	09/11/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.
Event or Problem Description
On (b)(6) 2020, a 12mm amplatzer septal occluder was selected for implant.During deployment, a cobra-deformation was noted.The device was pull back into the sheath and detached into the svcand the deformation was still noted.The occluder was snared though a large sheath.A 18mm amplatzer p.I.Muscular vsd occluder was implanted.The patient was transferred to the intensive care unit (icu) and was unstable.A few hours post procedure the patient became hemodynamically unstable.It was reported that the muscular vsd occluder had embolized into the right ventricle and the patient expired on (b)(6) 2020.
Additional Manufacturer Narrative
The reported event of deformation during deployment could not be confirmed.A more comprehensive 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.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note, per the instructions for use artmt100116885 rev.A, "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.".

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ST. JUDE MEDICAL, COSTA RICA LTDA; parque industrial, zona franca coyol s.a.; edificio #44b, calle 0, avenida 2, coyol; alajuela, costa rica 01897 -405; CS 01897-4050
• MDR Report Key: 10680622
• Report Number: 3008452825-2020-00561
• Device Sequence Number: 2954855
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: 00811806010090
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 9-ASD-012
• Device Catalogue Number: 9-ASD-012
• Device Lot Number: 6077480
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/21/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 10/23/2020
• 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-VSDMUSCPI-018, 7371484; 9-VSDMUSCPI-018, 7371484
• Outcome Attributed to Adverse Event: Death; Hospitalization; Required Intervention