MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® CARDIOFORM ASD OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number ASD37A

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923); Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 08/31/2022

Event Type  Injury  

Manufacturer Narrative

Patient weight is unknown.

Event Description

It was reported, the physician was implanting a 37mm gore® cardioform asd occluder to close a 17mm atrial septal defect (asd) with deficient rims.The device was placed and in good position, except it was hitting on the mitral valve.The physician chose to remove the device.The physician could not get the right disc to pull into the delivery catheter.With further manipulation, the retrieval cord broke.A snare was used to try to capture the device, but it was dislodged off the septum and embolized to the pulmonary artery.The device was snared, and part of the device was able to be captured into a 16 x 65 sheath.A balloon was used to pull the device 85% of the way into the sheath, but the physician was not able to pull it in any further.The physician did not want to pull the device with part of the left disc hanging out through the valves and other vasculature, so the patient was taken to surgery to remove the device and repair the asd.The patient was doing well following the procedure.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15428682
• MDR Text Key: 299970412
• Report Number: 2017233-2022-03322
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2022
• 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): Other
• Patient Age: 6 YR
• Patient Sex: Male