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

Catalog Number ASD37B

Device Problems Difficult to Fold, Unfold or Collapse (1254); Difficult to Remove (1528); Inadequacy of Device Shape and/or Size (1583)

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

Event Date 04/20/2022

Event Type  Injury  

Event Description

Alberta health services emailed gore customer service about a medical device incident involving a 37mm gore® cardioform asd occluder.Additional information received from the physician indicates that on (b)(6) 2022, the device was placed in a smaller patient.The device looked well seated across the septum and was locked; however, given the location of the defect and size of the patient, the right atrial disc was protruding into and obstructing the flow from the superior vena cava (svc).There was also a residual atrial septal defect (asd) shunt in the svc/retro-aortic area.The physician decided to remove the occluder and when it was brought back into the catheter, it did not collapse correctly and ultimately the wire ripped off.Many attempts were made to get the device out in the lab but were not successful, so the patient was urgently sent to the or for device retrieval and asd closure.The patient was doing well following surgery and was discharged home on (b)(6) 2020.

Manufacturer Narrative

Fluoroscopic case imaging was provided for evaluation.The images demonstrate a 37mm gore cardioform asd occluder successfully implanted over the asd.As reported, echocardiography imaging (not provided) showed the right disc was protruding out into the svc and potentially obstructing the svc flow.In addition, there was a residual shunt noted near the superior vena cava/retro-aortic region.Additional fluoroscopy images provided show unsuccessful attempts to snare the device.

Event Description

Alberta health services emailed gore customer service about a medical device incident involving a 37mm gore® cardioform asd occluder.Additional information received from the physician indicates that on (b)(6) 2022, the device was placed in a smaller patient.The device looked well seated across the septum and was locked; however, given the location of the defect and size of the patient, the right atrial disc was protruding into and obstructing the flow from the superior vena cava (svc).There was also a residual atrial septal defect (asd) shunt in the svc/retro-aortic area.The physician decided to remove the occluder and when it was brought back into the catheter, it did not collapse correctly and ultimately the wire ripped off.Many attempts were made to get the device out in the lab but were not successful, so the patient was urgently sent to the or for device retrieval and asd closure.The patient was doing well following surgery and was discharged home on (b)(6) 2022.

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.Fluoroscopic case imaging was provided for evaluation.The images demonstrate a 37mm gore cardioform asd occluder successfully implanted over the asd.As reported, echocardiography imaging (not provided) showed the right disc was protruding out into the svc and potentially obstructing the svc flow.In addition, there was a residual shunt noted near the superior vena cava/retro-aortic region.Additional fluoroscopy images provided show unsuccessful attempts to snare the device.The device was returned to gore for analysis.The engineering evaluation showed the occluder was damaged and did not have a retrieval loop attached.The delivery system was not returned and a comprehensive evaluation was not able to be performed.The physician¿s observation that the device separated from the retrieval cord is confirmed based on the event description and the imaging analysis.The likely cause for the retrieval cord separating from the device was either a break in the retrieval cord or the retrieval loop, however without either component returned, the exact cause was unable to be determined.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 14576030
• MDR Text Key: 293269088
• Report Number: 2017233-2022-02983
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD37B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/13/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 16 KG