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

Model Number 9-ASD-MF-025

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Erosion (1750); Cardiac Arrest (1762)

Event Type  Injury  

Manufacturer Narrative

Gtin -- unknown, serial/lot numbers are unknown.

Event Description

On an unknown date, a 25mm amplatzer cribriform occluder (aco) was implanted.As the patient was preparing for discharge the day following the procedure, the patient arrested.The patient was resuscitated and a bedside pericardiocentesis was performed.The patient was emergently taken to surgery where it was found that the aco had reportedly eroded through the right atrium into the aorta.The patient was stable post-operatively.

Manufacturer Narrative

Describe event or problem: updated.Model/lot 3: updated.Device manufacture date: updated.(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.Our investigation was limited to the review of the device history record, which showed that each manufacturing and inspection operation was performed and indicated complete in accordance with sjm specifications and procedures.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On (b)(6) 2016, a 25mm amplatzer cribriform occluder (aco) was implanted in the pfo of a patient with a history positive for a right parieto-occipital cva in (b)(6) 2015.The patient was preparing for discharge on (b)(6) 2016 when the patient was found lethargic and was hypotensive.The patient subsequently developed cardiac arrest and was resuscitated.A bedside pericardiocentesis (200cc) was performed and an echocardiogram demonstrated a large pericardial hematoma/clot which was compressing the rv.The patient was emergently taken to surgery where it was reported that the aco had eroded through the right atrium into the aorta.The defects were repaired and the patient was returned to the icu in stable but critical condition.The patient was discharged on (b)(6) 2016 in stable condition and the aco remains implanted.

• Brand Name: AMPLATZER CRIBRIFORM OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 5781870
• MDR Text Key: 49145181
• Report Number: 2135147-2016-00068
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Device Lot Number: 5381408
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention