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

Model Number 9-ASD-MF-030

Device Problems Difficult to Remove (1528); Unintended Movement (3026)

Patient Problem Embolism (1829)

Event Type  Injury  

Manufacturer Narrative

An event of "asymptomatic device embolization" was reported.The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information was obtained from a (b)(6) 2017 literature article titled, "retrieval of embolized amplatzer patent foramen ovale occlusion device: issues related to late recognition.The aim of the study was to present a case of asymptomatic device embolization recognized six months following implantation and the challenges encountered in successfully retrieving the device.Case report: the patient was referred for patent foramen ovale (pfo) closure and a 30mm amplatzer cribriform occluder (aco) was chosen for implantation.The aco position in the defect was confirmed with a "push-pull" maneuver prior to device release.The aco was released from the delivery cable uneventfully.The aco position was confirmed on fluoroscopy and tee.A tte was performed the following day and confirmed the aco was in a satisfactory position.The patient was discharged on aspirin and clopidogrel.A routine follow-up tte performed six months after implant and showed that the aco had embolized to the visceral abdominal aorta.There was no compromise of flow noted to either the visceral vessels or distal aorta.The aco was snared with a 20f gooseneck snare; however the aco could not be retrieved into the sheath as it would not compress.The gooseneck snare was exchanged to a 20f anl retriever; despite multiple attempts the aco would not compress.The aco was partially deformed and could be retracted into the right common iliac artery.Once the aco was positioned into the iliac, surgery was performed via a right sided rutherford morris incision and the aco was removed.A thrombectomy was required to remove a non-occlusive embolism from the tibia vessel believed to be chronic thrombus and fibrin that detached from the aco during snaring attempts.The patient was placed on apixaban and there were no recurrent thromboembolic complications during the 12 month follow-up.Conclusion: percutaneous pfo closure is an important therapeutic option in the treatment of cryptogenic stroke.Procedural complications are rare.In cases of late recognition of device embolization, the operator should be aware of the inability of these devices to retract and compress as they would when initially deployed which has implications for the potential for percutaneous retrieval.

• 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 ; 6517565400
• MDR Report Key: 6951481
• MDR Text Key: 89381851
• Report Number: 2135147-2017-00135
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: P000039/S013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/16/2017

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
• Device Operator: Health Professional
• Device Model Number: 9-ASD-MF-030
• Device Catalogue Number: 9-ASD-MF-030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2017
• Initial Date FDA Received: 10/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 58 YR