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 Problems Heart Block (4444); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 10/03/2021

Event Type  Injury  

Manufacturer Narrative

Article citation: santoro g, cuman m, pizzuto a, haxhiademi d, lunardini a, franchi e, et al."gore®cardioform asd occluder experience in transcatheter closure of ¿complex¿ atrial septal defects.Catheter cardiovasc interv.2021;1¿9.Https://doi.Org/10.1002/ccd.29977.Based on the study date range from january 2020 to march 2021, (b)(6) 2020 was determined best estimate of implant date.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 literature article was reviewed: santoro g, cuman m, pizzuto a, haxhiademi d, lunardini a, franchi e, et al."gore®cardioform asd occluder experience in transcatheter closure of ¿complex¿ atrial septal defects.Catheter cardiovasc interv.2021;1¿9.Https://doi.Org/10.1002/ccd.29977.The study's objective was to evaluate the efficacy and safety of the gore® cardioform asd occluder (gco) device for ¿complex¿ atrial septal defects (asd) closure.Between january 2020 and march 2021, 72 patients were classified into two groups based on their clinical/anatomic characteristics and submitted to transcatheter closure in a tertiary referral centre.As study endpoints, procedure success, safety, as well as early and mid-term clinical outcome were assessed in the whole population and compared between groups.Successful closure of ¿surgical¿ asds was achieved in 92% of cases.The article reports that at 1 month evaluation, residual atrial shunt was trivial in two patients.Echocardiographic evaluation showed residual shunt in one patient and mild superior caval vein flow turbulence due to device protrusion of the device in another patient.The article reports that during follow-up fluoroscopic evaluation, 23 of 55 patients showed wire frame fractures without any clinical or echocardiographic consequence.The article reports that one patient showed moderate tricuspid valve regurgitation due to septal leaflet impingement by a 44 mm device deployed in a 23.5 mm asd with deficient antero-inferior rim requiring surgical removal after 3 days.The article reports that one patient showed transient atrio-ventricular block after deployment of a 44 mm gco, successfully treated by short trails of corticosteroid therapy.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.Imdrf codes in this section also reflect the update from previously used fda to imdrf codes.D6b, if explanted, give date: provided date of best estimate.The date of event was determined to coincide with the publication date of the article.Implant and explant dates for the patient having undergone an explant of a gore® cardioform asd occluder were determined to represent estimates of best dates according to the time range provided in the article.According to the information in the article about the patient treated for arrhythmia, gore understands that the device remains implanted.The serial numbers for the gore® cardioform asd occluder devices involved in this case could not be obtained.Therefore, a review of the manufacturing records could not be performed.No information could be obtained with respect to the current location of the gore® cardioform asd occluder reported explanted in the literature article.This complaint was initiated based on information received from a literature article.Despite multiple attempts made over an extended period of time to obtain additional information from the corresponding author, the requested information was not received.The serial numbers for the gore® cardioform asd occluder devices involved in this case could not be obtained.Neither images enabling direct assessment of product performance nor the product itself, which was reported explanted for one patient, were returned for evaluation.Therefore, septal leaflet impingement reportedly causing moderate tricuspid valve regurgitation and the transient atrio-ventricular block post device deployment could not be independently confirmed during the investigation.The available information reported does not reasonably suggest a potential malfunction has occurred.The reported interventional procedure resulting in a device explant and the arrhythmia requiring medical treatment represent known complications or adverse events that can occur when using septal occluders and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.No allegation of device malfunction was indicated with respect to device performance.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.Adverse events associated with the use of the septal occluders may include, but are not limited to: interventional procedure, prescription medication, and new arrhythmia requiring treatment.

• 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: 14951641
• MDR Text Key: 295476288
• Report Number: 2017233-2022-03101
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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: 01/30/2024
• 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