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

Model Number	ASD32A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician was implanting a 32mm gore® cardioform asd occluder.The device was deployed and recaptured and locked, but due to a residual shunt it was decided to remove the device.While removing with the retrieval cord, the eptfe loop broke.The retrieval cord was still intact.About 90% of the device was recaptured into the delivery catheter when the loop broke.The physician chose to send the patient to surgery for defect closure and to remove the device and, ensure that it did not embolize during removal.
Additional Manufacturer Narrative
The analysis of the returned partial device stated: it was reported the physician was implanting a 32mm gore® cardioform asd occluder.The device was deployed and recaptured and locked, but due to a residual shunt it was decided to remove the device.While removing the device with the retrieval cord, the eptfe loop broke.The retrieval cord was still intact.About 90% of the device was recaptured into the delivery catheter when the loop broke.The physician chose to send the patient to surgery for defect closure and to remove the device and ensure that it did not embolize during removal.¿ only the delivery catheter and occluder with an attached syringe were returned.¿ the delivery catheter was kinked at the guidewire port.¿ the right eyelet was completely unraveled.¿ lock loop was unremarkable.The failure experienced could not be recreated during the evaluation.Thus, the cause of the complaint is unknown and cannot be determined from the evidence available.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Common Device Name: 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: 14042658
• Report Number: 2017233-2022-02846
• Device Sequence Number: 6301667
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: 00733132636495
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/07/2024
• Device Model Number: ASD32A
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/14/2022
• Supplement Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 04/07/2022
• Supplement Report FDA Received Date: 07/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 3 YR
• Patient Sex: Female
• Patient Weight: 8 KG