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

Catalog Number GSXE0030

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Hemorrhage/Bleeding (1888); Shock (2072); Rupture (2208)

Event Date 04/25/2017

Event Type  Death  

Manufacturer Narrative

Gsxe0030, lot: 15357417.(b)(4).Further investigation is being conducted and will be included in the final report.(b)(6).

Event Description

The patient presented with a patent foramen ovale (pfo) which was treated with a gore® cardioform septal occluder.One hour after procedure the patient suffered from a severe hemorrhagic shock.The performed echocardiography showed no abnormalities.The computed tomography scan, which was performed immediately identified a rupture of the inferior vena cava (ivc).The patient presented with a cardiac arrest which was refractory to resuscitation maneuvers.The patient expired.

Manufacturer Narrative

(b)(4).

Event Description

The following was reported to gore: the patient presented with a patent foramen ovale (pfo) which was treated with a gore® cardioform septal occluder.On hour after procedure the patient suffered from hemorrhagic shock.The patient lost 4l blood and became hypotensive.The performed echocardiography showed no abnormalities.The computed tomography scan, which was performed immediately identified a rupture of the inferior vena cava (ivc).The patient presented with a cardiac arrest which was refractory to resuscitation maneuvers.The patient expired.

Manufacturer Narrative

Patient id has too many characters; therefore the pat.Id (b)(6) is added.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• 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: ruth kunzmann ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6536330
• MDR Text Key: 74164569
• Report Number: 2017233-2017-00243
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2018
• Device Catalogue Number: GSXE0030
• Device Lot Number: 15357417
• 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: 08/08/2016
• 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: 76 YR
• Patient Weight: 72