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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Embolism (1498); Pain (1994); Thromboembolism (2654); Speech Disorder (4415); Ischemia Stroke (4418); Thrombocytopenia (4431); Thrombosis/Thrombus (4440)

Event Date 03/17/2022

Event Type  Injury  

Manufacturer Narrative

Device evaluated by manufacturer: the device remains implanted in the patient.Literature article citation: sara blanc-vannet, estelle vautrin, and nicolas piliero, ¿massive device thrombosis, multiple embolisms, and delayed-onset heparin-induced thrombocytopenia: a rare but severe complication of patent foramen ovale closure¿, european heart journal, volume 43, issue 25, 1 july 2022, page 2425.Https://doi.Org/10.1093/eurheartj/ehac126 online publish-ahead-of-print 17 march 2022.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.

Event Description

The following article was reviewed: sara blanc-vannet, estelle vautrin, and nicolas piliero, ¿massive device thrombosis, multiple embolisms, and delayed-onset heparin-induced thrombocytopenia: a rare but severe complication of patent foramen ovale closure¿, european heart journal, volume 43, issue 25, 1 july 2022, page 2425.Https://doi.Org/10.1093/eurheartj/ehac126 online publish-ahead-of-print 17 march 2022.The article reports that a gore® cardioform septal occluder was selected to treat a patent foramen ovale in a 40-year-old male 8 months after a cryptogenic stroke.Three weeks post implant however, the patient presented with right lower limb pain, pallor, and pulselessness of the distal arteries.Both computed tomography (ct) and transesophageal echocardiography (tee) imaging showed substantial thrombi in the right popliteal artery as well as on both sides sides of the pfo prosthesis, additionally segmental pulmonary embolism and a silent intraluminal left carotid artery thrombosis.Further analyses of blood values suggested a delayed-onset of heparin-induced thrombocytopenia and anti-blood clotting treatment with argatroban immediately ensued.The article also reports that 72 hours post hospital admission, the patient temporarily experienced wernicke¿s aphasia, with tee imaging identifying a similar sized, but mobile thrombus.Therefore, the decision was made to explant the gore® cardioform septal occluder including the thrombus and to surgically treat the patent foramen ovale.Patient recovery had been uneventful and the patient was discharged from hospital on warfarin, with the patient reportedly doing well at 6 months¿ follow up.

Manufacturer Narrative

H6: health effect - impact code: added code f12.H6: component code: added codes g04088, g04027.H6: type of investigation: added codes b11, b20.H6: investigation conclusions: added code d12.Multiple attempts were made over an extended period of time to obtain additional information from the corresponding author regarding this event.However, as no responses were received, this event was processed with the available information.H6: investigation findings: code c20: the serial number for the device involved in this event could not be obtained.Therefore, a review of the manufacturing records was not performed.No information was obtained about the availability of the explanted gore® cardioform septal occluder.Therefore, an explant evaluation could not be performed.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.According to the gore® cardioform septal occluder instructions for use (ifu), adverse events associated with the use of the occluder may include, but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.H6: health effect - clinical code: replaced codes e013302 and e050303 with codes e0131 and e050304.H6: investigation findings: replaced code c21 with code c20.H6: investigation conclusions: replaced code d16 with code d15.

• Brand Name: GORE® CARDIOFORM SEPTAL 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15282764
• MDR Text Key: 298476644
• Report Number: 2017233-2022-03267
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 40 YR
• Patient Sex: Male