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

Catalog Number ASD37E

Device Problems Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Detachment of Device or Device Component (2907); Migration (4003); Separation Problem (4043)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/20/2023

Event Type  Injury  

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.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

It was reported to gore a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect.After the device had been locked, it reportedly prolapsed towards the right atrium.In an attempt to bring back the device with the retrieval cord, the physician however found the cord had detached and the device then embolized completely into the right atrium.As another attempt to recapture the device using an amplatz goose neck¿ snare was also unsuccessful, the decision was made to perform surgery and remove the device that way.During surgery, it was found that the looking loop had become entangled in the tricuspid valve.No further issues were reported and the defect was closed successfully.The patient tolerated the procedure.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.Code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.D8 / d9: updated selections/information.H3 device evaluated by manufacturer: updated selection.Engineering evaluation summary - the gore® cardioform asd occluder asd37e/(b)(6) was returned incompletely to gore and an engineering evaluation was performed.The evaluation of the returned device showed the following: · a 229mm length of retrieval cord was returned with the device; however, no retrieval cord lock was returned.· the retrieval loop was intact.The physician¿s complaint was unable to be confirmed due to the retrieval cord lock not being returned.The retrieval cord returned with the device was verified to be approximately full length and the retrieval loop was intact; therefore, the retrieval cord did not break within the catheter assembly.It is possible that the retrieval cord broke at or near the knotted end of the retrieval cord lock; however, both ends of the retrieval cord appeared to be unknotted or damaged.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: device embolization.

Manufacturer Narrative

The evaluation of the device has been updated.Engineering evaluation summary: the gore® cardioform asd occluder asd37e/26132202 was returned incompletely to gore and an engineering evaluation was performed.The evaluation of the returned device showed the following: a 229mm length of retrieval cord was returned with the device and did not appear to be damaged or knotted; however, no retrieval cord lock was returned.The retrieval loop was intact.The physician¿s complaint was unable to be confirmed due to the retrieval cord lock not being returned.The retrieval cord returned with the device was verified to be approximately full length and undamaged and the retrieval loop was intact; therefore, the retrieval cord did not break within the catheter assembly.Codes provided in previous fu# 1 of mfr# 2017233-2023-04335 remain unchanged.

• 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: 17939134
• MDR Text Key: 325725069
• Report Number: 2017233-2023-04335
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD37E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/15/2022
• 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: 5 YR