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

Model Number	ASD32A
Medical Device Problem Codes	Fracture (1260); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	03/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician was implanting a 32mm gore® cardioform asd occluder to close a 15-16mm atrial septal defect.The defect had a deficient retroaortic rim.The device was positioned and locked, but as soon as the retrieval cord was removed, the inferior side of the right disc slid into the left atrium.A snare and a 12fr sheath were used to retrieve the device.The physician grabbed what was thought to be the right eyelet and began to pull the device into the sheath when she felt a ¿pop¿.The locking loop was still in the sheath, but the device had embolized to the left atrium.With more manipulation, the locking loop also pushed out of the sheath and rested in the left atrium.A snare was used to remove the locking loop and the sheath was upgraded to a 14fr sheath.A biopsy clamp was used to grab one of the petals of the device, but the petal broke off the device and was removed.The physician grabbed another petal, and again the petal broke off and was removed.The device was then captured with a snare and was successfully removed from the patient.A new 37mm device was implanted and the patient was doing well following the procedure.
Additional Manufacturer Narrative
The review or the images provided stated the following: in echo image one, the device can be well visualized.The posterior inferior portion of the device appears to be in the left atrium and the superior/ anterior portion of the device appears to be all in the right atrium.The device appears to still be contained by the retrieval cord but without additional imaging this cannot be confirmed.Additionally, in fluoro image one, the device is locked as visualized by the locking loop around the right atrial eyelet.The device does not appear in a good position.There appears to be a prolapse around the posterior inferior rim as evident by the excess petals of the device on the left atrial side.There is also no clear separation of disc petals around the anterior superior disc distinguishing left and right discs.However, this cannot be confirmed without additional echo imaging.The physician attempted to snare the device.¿the physician grabbed what was thought to be the right eyelet and began to pull the device into the sheath when she felt a ¿pop¿.The locking loop was still in the sheath, but the device had embolized to the left atrium.With more manipulation, the locking loop also pushed out of the sheath and rested in the left atrium.A snare was used to remove the locking loop and the sheath was upgraded to a 14fr sheath.A biopsy clamp was used to grab one of the petals of the device, but the petal broke off the device and was removed.The physician grabbed another petal, and again the petal broke off and was removed.The device was then captured with a snare and was successfully removed from the patient.¿ the cause of the locking loop separating from the device cannot be determined but it is presumed that the snare was around the locking loop and not around the right atrial eyelet.Without additional imaging of the snaring portion of the procedure, this cannot be confirmed.A new 37mm device was implanted and the patient was doing well following the procedure.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Additional Manufacturer Narrative
The evaluation of the returned device and images/videos showed the following: the lock release shuttle was in the fully locked position and the control shuttle was in the fully deployed position.The occluder was not attached to the delivery system.In its returned state, the occluder was attached to a snare.An occluder disc wire and the lock loop/bumper wire was found to have fractured from the occluder.The control catheter was found to be kinked at multiple locations along its length.All other delivery system components, including the sliding and locking mechanisms were unremarkable.The difficulty experienced while positioning the occluder, occluder embolization, and frame fracture could not be recreated during the evaluation.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: 16725339
• Report Number: 2017233-2023-03856
• Device Sequence Number: 8116488
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: 00733132636495
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 05/01/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/20/2025
• Device Model Number: ASD32A
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 04/12/2023
• Supplement Report FDA Received Date: 05/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/22/2022
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 31 KG