MAUDE Adverse Event Report: ST. JUDE MEDICAL INC-AGA MEDICAL CORP. AMPLATZER PFO OCCLUDER

Lot Number 100604352504297

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Discomfort (2330); Collapse (2416); Pericardial Effusion (3271)

Event Date 06/22/2017

Event Type  Injury  

Event Description

Pt with history of stroke/tia, as well as being status post device closure of a pt foramen ovale in 2012.Pt had some chest discomfort over the last 1-2 days after heavy exertion.The pt collapsed and was brought in through the ed and found to be hypotensive in extremis.A ct scan of the chest showed a moderate pericardial effusion with pericardial tamponade.Emergent surgery was necessary.The pt underwent a subxiphoid pericardial window with pericardial biopsy and insertion of a blake pericardial drain.The pt taken to the critical care unit for further monitoring.Over the subsequent several hours he drained more than a liter of blood from the pericardial drain.Emergent re-exploration was required and the pt was returned to the operating room.The chest was opened with a standard median sternotomy extending the incision into the subxiphoid window.There was active bleeding seen from the posteriolateral aspect of the aortic root just above the aorto-atrial junction.When the right atrium was explored the atrial septum appeared intact.There was an amplatz device in place which was well endothelialized.The device was excised.The surgeon could not see a specific tract going up into the aortic root, but suspected that the amplatz device put pressure on the roof of the left atrium that led to the development of a fistula into the adventitial tissues of the aortic root.The roof of the left atrium was closed.The interatrial septum was then also closed.The pt had stable hemodynamics and was transfer to the surgical icu for postoperative monitoring.Postoperative diagnosis was recurrent cardiac tamponade with atrial aortic fistula from an atrial septal defect closure device.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: PFO
• Manufacturer (Section D): ST. JUDE MEDICAL INC-AGA MEDICAL CORP.; st. paul MN 55117
• MDR Report Key: 6756493
• MDR Text Key: 81635705
• Report Number: MW5071310
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 100604352504297
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 49 YR
• Patient Weight: 71