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

Model Number	ASD44A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Disseminated Intravascular Coagulation (DIC) (1813); Septic Shock (2068)
Date of Event	01/26/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, the physician implanted a 44mm gore® cardioform asd occluder on (b)(6) 2023, to close an atrial septal defect (asd).The device was implanted with no issues.On (b)(6) 2023 the patient reported to the hospital with severe disseminated intravascular coagulation (dic) and septic shock.Symptom onset began approximately 48 hours post implant.The patient had been on plavix and aspirin.No history of anticoagulation problems or clotting disorders.The occluder was removed in a transcatheter procedure.The patient tolerated the procedure.A sample of the septal tissue showed no infection.The patient is suffering with hemolytic uremic syndrome (hus).
Additional Manufacturer Narrative
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
Device examination: the device was returned to w.L.Gore & associates for investigation.Submitted in formalin was a gore® cardioform asd occluder (asd).The graft material was diffusely tan/brown with a few small (< 5 mm diameter) brown/tan, lightly adherent, friable tissue plaques on the surface.Histopathological examination of surface adherent tissue and graft material from various areas on the device was performed.There was no evidence of bacterial colonization in the gross examination or in the sections examined.Fibrinous thrombus overlying and surrounding the graft biomaterial is the expected responses to the short duration implant.A few small areas of neutrophilic infiltration were present and could be a response to adjacent bacterial colonization but could also be resolving normal acute inflammation secondary to the device implant.Post-digestion evaluation was not performed, due to the nature of the compliant (possible infection).A review of the manufacturing records indicated the lot met all pre-release specifications.A review of the sterilization records indicated the lot met all pre-release sterilization specifications.

• 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: 16403626
• Report Number: 2017233-2023-03735
• Device Sequence Number: 17578202
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 02/27/2023

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2023
• Device Model Number: ASD44A
• Device Catalogue Number: ASD44A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2023
• Supplement Date Received by Manufacturer: 02/24/2023
• Initial Report FDA Received Date: 02/20/2023
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2020
• 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: 33 YR
• Patient Sex: Female
• Patient Weight: 121 KG