MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-2518

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Low Blood Pressure/ Hypotension (1914); Obstruction/Occlusion (2422); Asystole (4442)

Event Date 04/20/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on (b)(6) 2023, a 25-18mm amplatzer talisman pfo occluder was chosen for implant.After measurements of the defect were taken, a decision was made to choose the 25-18mm occluder due to patient anatomy and proximity of the aorta.During deployment, the implanting physician performed stabilization method "minnesota wiggle" and confirmed device was secure and released the device.After release, it was noted the device was still stable via intracardiac echocardiography (ice).The physician attempted to achieve better imaging of the occluder and began to move the ice probe around for a few minutes.At this point, it was noticed via fluoroscopy that the device had embolized to what the physician believed was the left atrium.It was reported the physician attempted to use a snare to retrieve the device in the left atrium for approximately 30 minutes but was not successful.The proctor requested the ice probe be moved around as they were unable to see the device and determined the device had embolized into the right atrium and not the left atrium.The physician retracted the sheath into the right atrium and continued his attempt to snare the occluder for another 30 minutes using fluoroscopy imaging only.It was reported the patient was hemodynamically stable until the physician moved the occluder while attempting to snare it to where the physician thought was the superior vena cava.The patient became extremely hypotensive and became asystole.Cardiopulmonary resuscitation (cpr) was performed for about 5 minutes, manual resuscitators to ventilate the patient were used, and cardiac surgery was called.The patient regained a pulse and was administered anesthesia for intubation while waiting for surgeon to arrive.During this time, it was reported the implanting physician continued his attempt to snare the device until the patient was transported out, which led the patient to go into asystole a second time.Cpr initiated again for about 5 minutes until patient regained pulse.The patient remained in the catheter lab for 20 minutes from time of first asystole episode until transfer to operating room (or).After the patient was transferred to operating room, implanting physician reviewed with proctor and stated he confirmed device was secure at time of release and believes he may have dislodged the device with the ice probe when trying to get additional images after the device was released.It was then reported on (b)(6)2023, the device was successfully explanted.The proctor followed up with the implanting physician on patient status and confirmed patient was stable.

Event Description

It was reported that on (b)(6) 2023, a 25-18mm amplatzer talisman pfo occluder was chosen for implant with a 9f amplatzer talisman delivery sheath.After measurements of the defect were taken, a decision was made to choose the 25-18mm occluder due to patient anatomy and proximity of the aorta.The patient's patent foramen ovale (pfo) measurements were: pfo tunnel 4mm, in right atrium - pfo to aortic roof 12.5mm /primum to pfo 13.5, in left atrium - pfo to aortic 9mm /primum to pfo 11 mm.During deployment, the implanting physician performed stabilization method "minnesota wiggle" and confirmed device was secure and released the device.After release, it was noted the device was still stable via intracardiac echocardiography (ice).The physician attempted to achieve better imaging of the occluder and began to move the ice probe around for a few minutes.At this point, it was noticed via fluoroscopy that the device had embolized to what the physician believed was the left atrium.It was reported the physician attempted to use a snare to retrieve the device in the left atrium for approximately 30 minutes but was not successful.The proctor requested the ice probe be moved around as they were unable to see the device and determined the device had embolized into the right atrium and not the left atrium.The physician retracted the sheath into the right atrium and continued his attempt to snare the occluder for another 30 minutes using fluoroscopy imaging only.It was reported the patient was hemodynamically stable until the physician moved the occluder while attempting to snare it to where the physician thought was the superior vena cava (svc) and caused partial obstruction of blood flow.The patient became extremely hypotensive and became asystole.Cardiopulmonary resuscitation (cpr) was performed for about 5 minutes, manual resuscitators to ventilate the patient were used, and cardiac surgery was called.The patient regained a pulse and was administered anesthesia for intubation while waiting for surgeon to arrive.During this time, it was reported the implanting physician continued his attempt to snare the device until the patient was transported out, which led the patient to go into asystole a second time.Cpr initiated again for about 5 minutes until patient regained pulse.The patient remained in the catheter lab for 20 minutes from time of first asystole episode until transfer to operating room (or).After the patient was transferred to or, implanting physician reviewed with proctor and stated he confirmed device was secure at time of release and believes he may have dislodged the device with the ice probe when trying to get additional images after the device was released.It was then reported on 21 april 2023, the device was successfully explanted via surgical removal and the pfo was surgically repaired.The proctor followed up with the implanting physician on patient status and confirmed patient was stable.

Manufacturer Narrative

An event of the device migration was reported.Information from the field indicated that the device may have been dislodged whilst the physician was using the ice probe to get the last images he requested of the deployed device after release.A returned device assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16936693
• MDR Text Key: 315298178
• Report Number: 2135147-2023-02116
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: 05415067033314
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-2518
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 8835668
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2023
• 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; Hospitalization
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 106 KG