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

Catalog Number ASD44A

Device Problems Expulsion (2933); Positioning Problem (3009)

Patient Problem No Code Available (3191)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Pma/510(k) # : p050006.(b)(4).The gore® cardioform asd occluder instructions for use list device embolization as a potential clinical and device adverse event.Furthermore, the recommended procedures section states: "measure the septal defect using fluoroscopy or echocardiography; the stop flow balloon technique is recommended, as described below: place a contrast filled, compliant balloon across the defect and gently inflate until shunting through the defect has stopped.Measure the diameter of the defect using either echocardiography or calibrated fluoroscopy." additionally, the recommended procedures section states, "the septal tissue margins surrounding the defect must be of sufficient size and integrity to prevent disc prolapse through the defect and gore® cardioform asd occluder embolization.".

Event Description

It was reported the physician implanted a 44mm gore® cardioform asd occluder to close an atrial septal defect with a static measurement of 15mm x 23mm and an inferior rim deficiency.The defect was not balloon sized.Approximately two hours following the procedure, the device embolized to the main pulmonary artery.The device was successfully removed with a snare.The defect was then balloon sized (non stop-flow method) to 36mm, and a 36mm amplatzer septal occluder device was implanted with no adverse effects.The physician and a gore field sales associate reviewed implant fluoroscopic imaging and noted that it appeared the device was prolapsing on the inferior rim.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 9447684
• MDR Text Key: 187240173
• Report Number: 2017233-2019-01233
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: ASD44A
• Device Lot Number: 16562781A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/02/2017
• 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: 12 YR
• Patient Weight: 44