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

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

Patient Problem Thrombosis/Thrombus (4440)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

It was reported to gore that the serial and item number of the device involved in this event cannot be retrieved.Therefore, a review of the manufacturing records cannot be performed.The device remains implanted.Therefore, an evaluation of the device cannot be performed.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 information was received from a post market clinical follow-up (pcmf) survey regarding the use of the gore® cardioform asd occluder.The data from the survey indicated that a gore® cardioform asd occluder was selected to treat an atrial septal defect on november 10, 2021 in a 18 year old female patient.The patient was reported to have presented without additional comorbidities.In the survey, the physician stated he had experienced complications with the use of the gore® cardioform asd occluder as on procedure day, phlebothrombosis in the absence of lung embolism was diagnosed.Additional information received from the agency stated that three weeks post procedure, the adverse event was reported resolved with an overall anticoagulant regimen over 3 months and also no observation of a post-thrombotic syndrome after the medication had been discontinued.When asked what best described the relationship between the thromboembolic event and the use of the gore® cardioform asd occluder, answer "possible" was selected.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.This complaint was initiated based on information received from a third party survey.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Available information reported in the complaint does not reasonably suggest a device related serious injury or a potential product malfunction has occurred.Thrombosis represents a known complication that can occur when using endovascular devices and can arise as a result of a multitude of factors, including intra-procedural considerations, post-implant treatment regimen and patient-related risk factors.However, it remains unknown if those points as recommended in the gore® cardioform asd occluder instructions for use were followed.Additionally, the physician reportedly does not consider the device to have caused or contributed to phlebothrombosis in this patient.According to the physician, accessing the patient via her groin did likely not contribute as there was a three week time period between the date of implant and the onset of phlebothrombosis.However, flue-like symptoms confining the patient to bed, tobacco, and contraceptive use were identified by the physician as potential risk factors having contributed to or caused the thrombotic incident.No further information was provided to gore.Based on the information received, this event does not meet the definition of a reportable device related serious incident.Therefore, gore retracts the report (manufacturer report number 2017233-2023-04512).B3, date of event: it was reported to gore that the reported phlebothrombosis was diagnosed three weeks post implant.Therefore, gore has determined december 01, 2021 to represent a best date estimate.

Event Description

The following information was received from a post market clinical follow-up (pcmf) survey regarding the use of the gore® cardioform asd occluder.The data from the survey indicated that a gore® cardioform asd occluder was selected to treat an atrial septal defect on (b)(6) 2021 in an 18 year old female patient with no additional comorbidities.Three weeks post procedure, phlebothrombosis on the patient's left side was reportedly diagnosed in the absence of lung embolism.As a remedial action, the physician treated the patient with anticoagulant medication over three months.Subsequent discontinuation of the therapy posed no issues and no post-thrombotic adverse event was observed.According to additional information received by gore, the physician does not consider the device to have caused or contributed to the thrombotic event.Reportedly, a thrombotic etiology could at best be assumed in the context of puncturing the patient's groin on the day of the implant, but this was unclear due to the long latency between implant and the thrombosis.Also, one week post implant the patient was reported to have suffered a flue-like infect confining the patient to bed and additional risk factors of tobacco use and taking contraceptives were stated.No further information was received for this patient.

• 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18409908
• MDR Text Key: 331509844
• Report Number: 2017233-2023-04512
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/02/2024

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 03/28/2024
• Supplement Dates FDA Received: 04/02/2024
• 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: 18 YR
• Patient Sex: Female
• Patient Weight: 48 KG