MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number 9-PDA-003

Device Problems Difficult or Delayed Positioning (1157); Activation, Positioning or Separation Problem (2906)

Patient Problems Hemorrhage/Bleeding (1888); Rupture (2208)

Event Date 04/21/2021

Event Type  Injury  

Event Description

A 5 french amplatzer sheath was advanced antegrade across the patent ductus into the descending aorta.A 5/4 amplatzer duct occluder was inserted into the sheath and advanced into the end of the sheath.The sheath was pulled back, and the retention disc was advanced out the end of the sheath.The entire apparatus was pulled back into the ductus.Multiple selective aortograms were performed to assess device position.Following appropriate positioning of the device, the device was released and the delivery system was removed.Shortly after release, the device spontaneously embolized into the descending aorta.A pigtail catheter was used to maintain stability of the device in the descending thoracic aorta.The 5 french amplatzer sheath was exchanged for a 6 french amplatzer sheath, which was advanced into the descending aorta.Using a variety of retrieval devices, attempts at antegrade retrieval of the device were made, but due to the anatomy of the ductus, this was not possible.Next, catheter manipulations were performed, and the device was repositioned within the ductus.Follow-up angiograms demonstrated the device in reasonable position within the ductal ampulla with a small residual shunt through the device.However, due to the original embolization of the device it was not felt this position was stable and surgical intervention was required.The decision was made to proceed with surgical patent ductus arteriosus (pda) ligation and removal of the occluder.Per cardiothoracic surgeon, chest entered through 4th intercostal space.Surgeon found a large tortuous pda, and noted that the occluder device could be felt in the aorta at the isthmus, but was not occluding flow, and the lower extremity arterial pressure was normal.Two ligaclip ligating clips were placed across the pda to close it.The aorta was then mobilized proximal and distal to the pda.A heavy silk tie was placed around the aorta proximal and distal to the duct to get control.The aorta was then clamped proximal and distal at the site of the circumferential loose silk ties.A small incision was made transversely in the aorta at the isthmus, and the device was immediately visible and removed through the incision.The aortotomy was then closed with a 5-0 prolene suture.The aorta was de-aired just prior to clamp removal by removing the distal clamp first and allowing a small amount of bleeding and de-ailing of the aorta.Once the suture was tied, the proximal clamp was removed.Echocardiogram the following day showed flail anterior tricuspid leaflet secondary to ruptured chordae, likely due to catheter manipulation during cardiac cath, resulting in moderate tricuspid insufficiency.The ventricular function of the patient was normal without residual pda.Pediatric patient recovered quickly, and was discharged home 2 days later.

Event Description

A 5 french amplatzer sheath was advanced antegrade across the patent ductus into the descending aorta.A 5/4 amplatzer duct occluder was inserted into the sheath and advanced into the end of the sheath.The sheath was pulled back, and the retention disc was advanced out the end of the sheath.The entire apparatus was pulled back into the ductus.Multiple selective aortograms were performed to assess device position.Following appropriate positioning of the device, the device was released and the delivery system was removed.Shortly after release, the device spontaneously embolized into the descending aorta.A pigtail catheter was used to maintain stability of the device in the descending thoracic aorta.The 5 french amplatzer sheath was exchanged for a 6 french amplatzer sheath, which was advanced into the descending aorta.Using a variety of retrieval devices, attempts at antegrade retrieval of the device were made, but due to the anatomy of the ductus, this was not possible.Next, catheter manipulations were performed, and the device was repositioned within the ductus.Follow-up angiograms demonstrated the device in reasonable position within the ductal ampulla with a small residual shunt through the device.However, due to the original embolization of the device it was not felt this position was stable and surgical intervention was required.The decision was made to proceed with surgical patent ductus arteriosus (pda) ligation and removal of the occluder.Per cardiothoracic surgeon, chest entered through 4th intercostal space.Surgeon found a large tortuous pda, and noted that the occluder device could be felt in the aorta at the isthmus, but was not occluding flow, and the lower extremity arterial pressure was normal.Two ligaclip ligating clips were placed across the pda to close it.The aorta was then mobilized proximal and distal to the pda.A heavy silk tie was placed around the aorta proximal and distal to the duct to get control.The aorta was then clamped proximal and distal at the site of the circumferential loose silk ties.A small incision was made transversely in the aorta at the isthmus, and the device was immediately visible and removed through the incision.The aortotomy was then closed with a 5-0 prolene suture.The aorta was de-aired just prior to clamp removal by removing the distal clamp first and allowing a small amount of bleeding and de-aiing of the aorta.Once the suture was tied, the proximal clamp was removed.Echocardiogram the following day showed flail anterior tricuspid leaflet secondary to ruptured chordae, likely due to catheter manipulation during cardiac cath, resulting in moderate tricuspid insufficiency.The ventricular function of the patient was normal without residual pda.Pediatric patient recovered quickly, and was discharged home 2 days later.

• Brand Name: AMPLATZER
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11811806
• MDR Text Key: 250240536
• Report Number: 11811806
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-PDA-003
• Device Lot Number: 7754442
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/30/2021
• Event Location: Hospital
• Date Report to Manufacturer: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 365 DA
• Patient Weight: 7