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

Catalog Number	ASD44A
Medical Device Problem Codes	Expulsion (2933); Positioning Problem (3009)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/13/2019
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9447684
• Report Number: 2017233-2019-01233
• Device Sequence Number: 19385136
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/13/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2020
• Device Catalogue Number: ASD44A
• Device Lot Number: 16562781A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 12 YR
• Patient Weight: 44