MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN DELIVERY SHEATH; CATHETER, PERCUTANEOUS

Catalog Number 9-TDS-09F45-80

Device Problems Improper or Incorrect Procedure or Method (2017); Air/Gas in Device (4062)

Patient Problems Air Embolism (1697); Angina (1710); Atrial Fibrillation (1729); Hypoxia (1918)

Event Date 03/16/2023

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 patent foramen ovale (pfo) occluder was selected for implant using a 9f amplatzer talisman delivery sheath in patient with history of stroke.The patient was consciously sedated for procedure.A non-abbott 8fr intracardiac echocardiogram (ice) catheter was used to obtain images/measurements of the patient's atrial septum.The pfo was visualized in the septum and was crossed using an unknown table guidewire and unknown 6fr multipurpose catheter.The guidewire was advanced into the upper left pulmonary vein.The 9f amplatzer talisman delivery sheath was advance over the guidewire and into the left atrium.The 25-18mm amplatzer talisman (pfo) occluder was then prepared for implant as per the instructions for use.The unknown guidewire and dilator were removed slowly from the delivery sheath to prevent air ingress.A wet-to-wet connection was established between the occluder and delivery sheath and the occluder was advanced to the left atrium.The left atrial disc of the 25-18mm amplatzer talisman (pfo) occluder was deployed under intracardiac echocardiogram and fluoroscopic guidance.The left atrial disc was brought back to the inter-atrial septum and the right atrial disc was deployed.A tug test was performed along with a color flow assessment via ice.The was determined that the occluder was in an optimum position and full release from the delivery cable was conducted.Immediately following release/implant of the occluder it was noted via electrocardiogram, that the patient went into atrial fibrillation and an st elevation was noted.It was also noted during st elevations the patient's oxygen saturation dropped to the low 90% range.It was noted via ice that there were micro air embolisms present in the aortic route.There was no leak observed/discovered in the 9f amplatzer talisman delivery sheath.It was noted that the delivery sheath was drawn back on the and all connections were checked to make sure air was not being introduced from the delivery sheath on the right side.It was noted that there was no contrast injected and there was no syringe attached to the 9f amplatzer talisman delivery sheath.All components (hemostasis valve, 25-18mm amplatzer talisman (pfo) occluder, loader, dilator etc.) were flushed with sterile saline during device preparation.There was no reported difficulty/issue reported implanting/placing the occluder.However, it was noted that blood backflow allowed to purge any possible air from the 9f amplatzer talisman delivery sheath was not allowed/performed.The decision was made to place the patient on 100% oxygen and the st elevation diminished thereafter.The patient complained of chest pain.A cardioversion was performed due to the patient's atrial fibrillation.It was noted after, that the patient's chest pain and st elevation resolved.The patient was stable leaving the operating room and was kept overnight for observation.The implanting physician alleges that some air must have been in the occluder, loader, or tuohy of the delivery sheath that led to the air embolisms, but no direct cause has been established.The patient was discharged at the time of report.

Manufacturer Narrative

N event of st elevation and atrial fibrillation was reported.The device was returned to abbott, and the investigation confirmed that several kinks were found on the loader and delivery sheath, consistent with damage during use or due to shipment back to abbott for analysis.The loader was connected to the hemostasis valve, which was connected to the extension tube and stopcock.The delivery cable was inserted through the hemostasis valve and tightened.The loader was connected to the sheath.A syringe was attached to the stopcock, and the components were flushed with water.No leaks or bubbles were found.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 root cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• Brand Name: AMPLATZER TALISMAN DELIVERY SHEATH
• Type of Device: CATHETER, PERCUTANEOUS
• 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: 16709573
• MDR Text Key: 312986827
• Report Number: 2135147-2023-01558
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212738
• 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: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9-TDS-09F45-80
• Device Lot Number: 8564197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2022
• 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): Hospitalization; Other; Required Intervention; Life Threatening
• Patient Age: 60 YR
• Patient Sex: Male