MAUDE Adverse Event Report: GORE HELEX SEPTAL OCCLUDER

Device Problem Material Twisted/Bent (2981)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 02/19/2015

Event Type  Injury  

Event Description

Pt had a helix septal occluder implanted at another facility in their cath lab.Pt had a large residual asd in the superior and anterior position, plus the discs of the helix device were very close to the mitral and tricuspid valve.Pt then scheduled for surgical repair.Upon examination of the helix device it was securely adherent in the antero-inferior portion of the asd, however, there was not much adhesion to the superior, most of the anterior and posterior rim.The device was removed.The left (laft) disc was noted to be folded over itself.The wire frame was intact.

• Brand Name: SEPTAL OCCLUDER
• Type of Device: SEPTAL OCCLUDER
• Manufacturer (Section D): GORE HELEX; flagstaff AZ 86003
• MDR Report Key: 4664958
• MDR Text Key: 5730931
• Report Number: MW5041905
• Device Sequence Number: 1
• Product Code: MLV
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Other Device ID Number: AP3432-ML1 (BAR CODE)
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE KNOWN
• Patient Outcome(s): Hospitalization
• Patient Age: 19 YR
• Patient Weight: 62