MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-ASD-020

Device Problems Migration or Expulsion of Device (1395); Human-Device Interface Problem (2949)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/15/2021

Event Type  Injury  

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

It was reported on (b)(6) 2021, a 20mm amplatzer septal occluder was selected for implant.After positioning, the doctor performed the "wiggle" test and waited 5 minutes.The doctor performed another "wiggle" test and pulled the sheath down a little so the cable could move loosely and during that time a transesophageal echocardiogram (tee) was performed and a small cranial/posterior shunt was noted.The doctor wanted to implant a 22mm but didn't.After the tee another "wiggle" test was performed and the occluder fit well.Soon after the occluder embolized and was positioned in front of the aortic valve.The occulder did not block or damage any valves and blood was still able to flow through.A 12f sheath and cardio forceps were used to guide the occluder over the aorta and into the grown.It was then retrieved via a 20f sheath.The mitral, aortic valve, septum and pericardium were checked on tee and nothing was noted.The angio of the vessels were also normal.No device was implanted.The patient received a ct scan and is being monitored.On (b)(6), the patient was operated on during the night due to 2 small lesions possible due to the guidewire causing the bleed into the abdomen.The patient is doing well due to the circumstances.

Manufacturer Narrative

An event of residual shunt and device embolism was reported.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.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12511816
• MDR Text Key: 272668916
• Report Number: 2135147-2021-00375
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: 00811806010175
• 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: 10/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 6910041
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention