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

Catalog Number ASD44J

Device Problems Break (1069); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problem Unspecified Heart Problem (4454)

Event Date 10/18/2023

Event Type  Injury  

Event Description

On (b)(6) 2023, this patient underwent a treatment to close a 19 mm stop-flow balloon sized atrial septal defect using 44 mm gore® cardioform asd occluder.Reportedly, the patient¿s left atrial roof was small in space.At first attempt to deploy the occluder, the left atrial disc prolapsed.At the second attempt, a residual shunt was observed.The physician considered that left atrial space is small for the selected size of the occluder, and adjusting angle of the occluder to fit to the septum is being difficult.Therefore, he removed the occluder once and decided to reshape the proximal tip of the device.While physician was manually reshaping the proximal tip of the device, a snapping sound was heard.The physician then put the device in water and made sure it can be properly deployed and restored.Since no issues were observed in the water, the device was inserted again to the patient.Upon deploying the left atrial disc, the angle of the occluder diverged from the catheter.It was confirmed under fluoroscopic image that the mandrel was broken off at about 2.5 cm distal to the left atrial eyelet.The broken proximal portion of the mandrel with the occluder was still connected to the delivery system with the locking loop.The physician inserted an 8-fr sheath from internal jugular vein and attempted to lift the left atrial eyelet upward using a 6-fr snare to align its angle with the catheter.The attempt was unsuccessful, therefore, the 6-fr sheath was replaced to a 12-fr sheath and two snares (6-fr and 4-fr) were used to capture the left atrial eyelet.The occluder was successfully recaptured and the device was retracted into a long sheath.The device was removed through inferior vena cava.The femoral vein was cut down from which the device was successfully taken out of the patient.Non-gore device (figulla® flex ii, japan lifeline co., ltd) was used as a replacement and the atrial septal defect was successfully closed.The patient tolerated the procedure.The physician stated that he might have applied to much pressure at one point while reshaping the proximal tip of the device, causing the damage to the mandrel.It was reported that device might have been initially damaged outside of the patient for which the mandrel become completely broken off while being advanced inside the patient.

Manufacturer Narrative

A1: no patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.H3: code "other" was selected as the medical device was discarded at facility.Return not possible.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.

Manufacturer Narrative

H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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: aya shinoda ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18127617
• MDR Text Key: 327994586
• Report Number: 2017233-2023-04401
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASD44J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG