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

Catalog Number ASD44E

Device Problem Migration (4003)

Patient Problems Bradycardia (1751); Tachycardia (2095); No Code Available (3191)

Event Date 11/24/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The gore® cardioform asd occluder instructions for use list device embolization as a potential clinical and device adverse event.Note: the physician stated there were no problems with the gore devices.The patient's anatomy was better suited for surgical closure.

Event Description

It was reported the physician selected a 37mm gore® cardioform asd occluder to treat an atrial septal defect balloon sized to 22mm x 23mm.The patient had an absent anterior-superior rim and the other rims were thin and floppy.The 37mm device was deployed but was not stable and was removed without issue.A 44mm gore® cardioform asd occluder was selected.Following deployment, no shunt was visible; however, after the occluder was locked and released, a mild shunt was noted through the anterior-inferior rim.The physician decided to snare the device.During the attempted snare, the device embolized into the left atrium.At this point the patient experienced tachycardia and a drop in blood pressure so the physician opted to send the patient to surgery for device removal and defect closure.The surgery was successful and there were no reported adverse effects.

Manufacturer Narrative

Correction - h6: health effect impact code 4643 "blood transfusion" was submitted in the prior report but is incorrect as this patient did not require a blood transfusion.

Manufacturer Narrative

Correction - h6: health effect - clinical code, updated to tachycardia.The original report was incorrectly coded as bradycardia.Additions - h6: health effect - impact codes, added codes 4627 and 4643; added code 22 to investigation conclusions.The gore® cardioform asd occluder instructions for use list arrhythmia as a potential clinical and device adverse event.

• 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
• MDR Report Key: 11030814
• MDR Text Key: 222319379
• Report Number: 2017233-2020-01546
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 02/12/2021

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 Expiration Date: 01/14/2023
• Device Catalogue Number: ASD44E
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/24/2020
• Initial Date FDA Received: 12/17/2020
• Supplement Dates Manufacturer Received: 11/24/2020; 11/24/2020
• Supplement Dates FDA Received: 02/12/2021; 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 12 YR
• Patient Weight: 45