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

Catalog Number GSX0030A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Cardiopulmonary Arrest (1765); Embolism (1829); Hemorrhage/Bleeding (1888); Rupture (2208); Vascular Dissection (3160)

Event Date 09/21/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device was discarded, so no engineering investigation could be performed.Udi: (b)(4).

Event Description

It was reported the physician was implanting a gore cardioform septal occluder to close a patent foramen ovale.After multiple attempts the device was deployed and locked with good apposition to the septum.The night following the procedure the patient had a bowel movement.Under valsalva the device embolized to the aorta.One day post procedure the physician planned to retrieve the device.A 12fr sheath was advanced and the device was pulled to the sheath with a snare.There was too much torque in the system and the physician was unable to pull the device into the sheath.The physician then advanced a 16fr sheath with a biopsy instrument.The physician grabbed the device with the biopsy instrument and pulled it down to the iliac artery.At this point in the procedure the patient experienced stomach pain.On imaging the physician saw a ruptured iliac and a dissection of the aorta.An atrium device was advanced and deployed in attempt to stop the bleeding in the iliac.The patient coded twice and was sent to emergency surgery for repair of the vessels and removal of the goreardioform septal occluder.The patient was doing well following surgery.

• 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: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6037359
• MDR Text Key: 57777030
• Report Number: 2017233-2016-00803
• 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: 09/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/13/2018
• Device Catalogue Number: GSX0030A
• Device Lot Number: 15168696
• 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: 06/13/2016
• 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): Other
• Patient Age: 57 YR
• Patient Weight: 107