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

Model Number 9-ASD-012

Device Problem Material Deformation (2976)

Patient Problem Death (1802)

Event Date 09/11/2020

Event Type  Death  

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 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.

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
• Type of Device: 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
• MDR Text Key: 211369634
• Report Number: 3008452825-2020-00561
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010090
• UDI-Public: 00811806010090
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9-VSDMUSCPI-018, 7371484; 9-VSDMUSCPI-018, 7371484
• Patient Outcome(s): Death; Hospitalization; Required Intervention