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

Catalog Number GSX0030A

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Arrest (1762); Death (1802); Pericardial Effusion (3271)

Event Date 05/16/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The gore® cardioform septal occluder instructions for use includes, but is not limited to the following potential device or procedure-related adverse events associated with the use of the occluder: significant pleural or pericardial effusion requiring drainage, cardiac arrest and death.

Event Description

It was reported to gore a 30 mm gore® cardioform septal occluder was selected to close a patent foramen ovale.It was reported the physician tried to cross the defect prior to intracardiac echocardiogram (ice) using an sl 2 or 4 catheter, but was unsuccessful.Ice was then placed and the tunnel was able to be crossed with the sl catheter; however they were unable to access the left pulmonary vein.Access was gained to the right upper pulmonary vein, at which point the soft wire was exchanged for a stiffer 180 j wire.The gore® cardioform septal occluder delivery catheter was then advanced.The left disc was deployed and positioned on the septum.The right disc was then deployed.At this time it was reported the patient¿s pressure began to drop.The device had not been locked and was removed at this time.It was reported 1-2 60 cc syringes were used in treatment for a pericardial effusion; however, the patient went into cardiac arrest and chest compressions and medications were initiated.It was reported the patient did not survive.

• Brand Name: GORE® CARDIOFORM SEPTAL 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: kathy titus ; 9285263030
• MDR Report Key: 7554231
• MDR Text Key: 109617731
• Report Number: 2017233-2018-00309
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• 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: 05/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2019
• Device Catalogue Number: GSX0030A
• Device Lot Number: 17568621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• 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): Death
• Patient Age: 68 YR
• Patient Weight: 91