MAUDE Adverse Event Report: AGA MOEDICAL CORP AMPLATZER; DUCT OCCLUDER

Model Number 9-PDA-005

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

Using duct occluder in cath lab to close pda.Physician chose an 8/6 amplatzer pda occluder.Pda was crossed from the pulmonary artery end.Long delivery sheath advanced through the right side of the heart and across the pda into the descending aorta.Device delivered with the disc portion pulled up against the ductal ampulla.The sheath was pulled back and the rest of the device was uncovered.Device appeared somewhat wide on the disc end, the other potion appeared to be long and stretched out which felt to be consistent with duct in spasm as previously noted on ekgs.Attempted to resheath the device in an attempt to re deliver the disc in a flatter configuration.Was unable to pull the device back into the sheath.Made decision to then push the disc portion out against the back wall of the descending aorta against the back wall of the aortic arch.This appeared to flatten the disc some, then pulled the device back into the pda and unsheathed it.A repeat angiogram showed the device to be in good position with complete occlusion.The device was then released.On release the device was noted to go from its horizontal position back into a more diagonal superior to inferior position.The device did not move out of the pda at all.A repeat angiogram showed that the device appeared to still be within the duct, however there was now a residual jet.Pull backs were done across the ascending and descending aortas without any gradient.In addition there was a pull back from the lfa into the mpa without any gradient.The pt had good pulses in left foot.Decision made not to attempt to retrieve the device.Catheters and sheaths were then removed.Echocardiogram performed and as had been anticipated the lv function was decreased which is commonly seen after a significant chronic lv volume load is removed.Pt started on milrinone.B/ps remained fine throughout this time period.Repeat images of the lv demonstrated the shortening fraction to have normalized to 32 percent.Device still appeared to be within the pda; however, it appeared as though the anterior portion of the aortic arch was being distorted by the disc portion of the pda in its current configuration.There was no gradient by echocardiogram or by right arm and left leg blood pressures.There appeared to be a small residual shunt.After talking with cardiothoracic surgeon decision made to take the pt to the operating room to remove the device and do a pda ligation.Pt was clinically stable throughout all of this time and there was no significant hemodynamic compromise r/t the device.

• Brand Name: AMPLATZER
• Type of Device: DUCT OCCLUDER
• Manufacturer (Section D): AGA MOEDICAL CORP; 5050 nthan lane north; plymouth MN 55442
• MDR Report Key: 3834893
• MDR Text Key: 18568813
• Report Number: 3834893
• Device Sequence Number: 1
• Product Code: MAE
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/16/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 9-PDA-005
• Device Lot Number: 4518547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/16/2014
• Distributor Facility Aware Date: 05/13/2014
• Event Location: Hospital
• Date Report to Manufacturer: 05/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 9 MO
• Patient Weight: 5