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

Lot Number 15197656

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Atrial Fibrillation (1729); Device Embedded In Tissue or Plaque (3165)

Event Date 04/27/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device could not be conducted because the lot # remains unknown.The device remains implanted so no engineering investigation could be performed.(b)(4).

Event Description

It was reported the physician implanted a gore® cardioform septal occluder to close an atrial septal defect on (b)(6) 2016.On (b)(6) 2018 the physician attempted a trans-septal puncture for atrial fibrillation ablation and it was noted the device had embolized and was no longer on the atrial septum.The patient was normal sinus rhythm and stable following the procedure.Removal of the embolized device was scheduled for (b)(6) 2018.When attempting to retrieve the embolized device, the device was endothelialized in the left pulmonary artery.The device was left in the pulmonary artery.The patient was doing well following the procedure.The patient will be brought back at a later date for defect closure.

Manufacturer Narrative

Additions: lot #, unique identifier (di), and expiration date.Device manufacture date.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7535977
• MDR Text Key: 108976872
• Report Number: 2017233-2018-00299
• 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
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/21/2018
• Device Lot Number: 15197656
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 58 YR
• Patient Weight: 128