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

Catalog Number ASD32J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 01/19/2023

Event Type  Injury  

Manufacturer Narrative

The lot # was requested, but was not available.Title: anatomical considerations in cases of atrioventricular block after percutaneous atrial septal defect closure source: 33th annual meeting of japanese society of congenital interventional cardiology.

Event Description

The following publishment was reviewed by gore: title: anatomical considerations in cases of atrioventricular block after percutaneous atrial septal defect closure source: 33th annual meeting of japanese society of congenital interventional cardiology.Case 4: a patient (6 yo, 16 kg, man) underwent treatment to close multiple 11 x 9 mm and 3 x 3 mm atrial septal defects with bald aortic rim, 7.6 mm coronary sinus rim, 5.8 mm tricuspid valve rim using 32 mm gore® cardioform asd occluder (gca).During the treatment, at a moment the occluder was locked, 1st degree atrioventricular block (avb) appeared.The avb improved within minutes and the occluder was released.After 12 hours, a wenckebach avb was appeared.The w-avb improved 3 days postoperatively.After confirmation of avb, mpsl was administered.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16722761
• MDR Text Key: 313103782
• Report Number: 2017233-2023-03854
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD32J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2023
• 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: 6 YR
• Patient Sex: Male
• Patient Weight: 16 KG