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

Catalog Number ASD37E

Device Problems Mechanical Problem (1384); Material Separation (1562); Device Dislodged or Dislocated (2923); Migration (4003)

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

Event Date 08/15/2023

Event Type  Injury  

Manufacturer Narrative

H6, type of investigation, code b15: gore has received medical images and an evaluation is currently being performed.H6, investigation findings, code c19: the review of the manufacturing paperwork verified that the lot involved in this event met all pre-release specifications.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

It was reported to gore a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 19mm and using transesophageal echocardiography.The device was placed and subsequently locked in a good position.However, upon locking, the device reportedly dislodged and it was therefore decided to remove the device.The physician was reportedly unable to engage the locking loop with the delivery catheter and attempted to recapture the device.When most of the device portion was in the delivery catheter, the retrieval cord reportedly broke and the device embolized.To solve the situation, the physician snared and removed the device from the patient.The patient tolerated the procedure.

Manufacturer Narrative

D8/d9: updated data in this section emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.Imaging evaluation summary: an electronic file containing digital cine fluoroscopy images was received by gore and an imaging evaluation was performed.The imaging evaluation summary states the following: it was reported to gore a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 19mm using transesophageal echocardiography.It was reported that during the locking process, the device dislodged.It was also reported that during the attempt to retrieve the device, retrieval cord broke and the device embolized.The device was snared with most of the device withdrawn into the sheath.Fluoroscopy imaging shows that the device was being pulled into the inferior vena cava towards the access site, but at the level of the pelvic rim, the device can be observed with a substantially greater length of the device extending from the end of the sheath.It was reported that the device was removed from the patient and that the patient tolerated the procedure.Product evaluation summary: the gore® cardioform asd occluder asd37e/(b)(6) was returned to gore and an engineering investigation was performed.The complaint that the retrieval cord broke could not be confirmed, as it appeared to be complete and undamaged.The complaint that the device did not lock could not be confirmed, and there was no apparent damage to the lock loop.The eyelet appearance confirms the difficulty experienced re-loading the occluder.This complaint was initiated based on information received from the field.The product was returned for evaluation.The investigation confirmed that breakage of the device's retrieval cord did not occur as the cord appeared undamaged.Also, the reported observation that the device did not lock could not be confirmed.Our evaluation concludes there were difficulties during reloading the device due to the appearance of the eyelet.The reported device embolization represents a known complication or adverse event 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.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.According to the gore® cardioform asd occluder instructions for use (ifu), adverse events associated with the use of the occluder may include, but are not limited to: device embolization.

• 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: 17726282
• MDR Text Key: 323153645
• Report Number: 2017233-2023-04265
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2022
• 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: 22 YR
• Patient Weight: 71 KG