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

Catalog Number ASD37E

Device Problems Break (1069); Device Dislodged or Dislocated (2923); Migration (4003)

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

Event Date 01/30/2024

Event Type  Injury  

Manufacturer Narrative

Gore is currently reviewing the manufacturing records associated with this device.The device was returned to gore and an engineering evaluation will 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

It was reported to gore a 37 mm gore® cardioform septal occluder was selected to treat an atrial septal defect with a limited aortic rim.No issues were reported during deploying and locking the device.Subsequently, both transesophageal echocardiography and fluoroscopy imaging showed that the right disk appeared to have moved and was now on the left side.An attempt was made to retrieve the device utilizing the retrieval cord but it was not possible to engage the right atrial eyelet and the locking loop with the grey delivery catheter.It was then observed that the grey catheter was kinked at the mandrel.I was also reported that during the retrieval attempts, the device became unlocked.Over the next 1.5 hours, multiple unsuccessful attempts were performed to retrieve the device through a 16 french long sheath, using different lengths and types of snares.Reportedly, a 25 mm goose neck snare initially caught the device and the right atrial eyelet, but due to the inner grey catheter, the device could not be brought into the long sheath.In this situation, the decision was made to send the patient for surgery and the delivery system, retrieval cord and the device were successfully removed.Also, the atrial septal defect was surgically closed.The patient tolerated the procedure.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.H6, investigation findings, code c19: the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.Product evaluation summary - the gore® cardioform asd occluder asd37e/(b)(6) was returned to gore.The investigation of the device showed the following: the delivery system was returned in a fully deployed and unlocked state.The occluder was detached from the delivery system and had been locked.The occluder had a kink in the frame of the left disc.The retrieval cord was sheared.The delivery catheter was damaged at the guidewire port.The physician¿s claim that the device right disc appeared to have moved after locking was unable to be confirmed through the evaluation.The kinked delivery catheter was confirmed through the evaluation, but no root cause could be determined as the delivery system was loaded into the shipping bag in a way that appeared to have caused a kink.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.H6, medical device problem code: a010402 migration was withdrawn.This complaint was initiated based on information received from the field.No intra-operative images from the day of implant were returned to gore and given the returned state of the device and the delivery system, it is not possible to replicate what the physician experienced during the procedure.Gore's findings suggest that the kink in the frame of the left disc as well as the broken retrieval cord were likely due to the multiple failed retrieval attempts made by the physician.The physician¿s claim that the device right disc appeared to have moved after locking could not be confirmed during the evaluation.Additionally, the kink in the delivery catheter likely happened when the device was returned to gore and loaded into the shipping bag in way that appeared to have caused the kink.Interventional surgery can occur when using septal occluders and can arise as a result of a multitude of factors, including intraprocedural technical considerations and patient-related risk factors.No allegation of a device malfunction was found during our investigation impacting device performance.Based on the incident description and the subsequent investigation, 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: complications requiring surgery.

• 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: 18765807
• MDR Text Key: 336049902
• Report Number: 2017233-2024-04654
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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
• Device Catalogue Number: ASD37E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/23/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2023
• 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: 29 YR
• Patient Sex: Female
• Patient Weight: 58 KG