FDA.reportPublic FDA data

MAUDE MDR 2058322

MDR report key
2058322
Report number
2017233-2011-00180
Event key
0
Event type
3
Date of event
2011-03-19
Date received
2011-04-08
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BENJAMIN FILLERUP
Address
1500 NORTH FOURTH ST. FLAGSTAFF AZ 86004 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE HELEX SEPTAL OCCLUDERMLV/OCCLUDER, TRANSCATHETER SEPTALW.L. GORE & ASSOCIATESMLVWLG216HX20258560169N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-04-0801. R

Event Narratives#

D

Patient 1

IT WAS REPORTED THE PHYSICIAN IMPLANTED A GORE HELEX SEPTAL OCCLUDER TO CLOSE AN ATRIAL SEPTAL DEFECT ON (B)(6) 2011. THE DEFECT WAS NOT BALLOON SIZED AND THE POOR PERIPROCEDURAL ECHOCARDIOGRAPHY MADE VIEWING THE OCCLUDER DIFFICULT. ON (B)(6) 2011, POST PROCEDURE ECHOCARDIOGRAPHY SHOWED THE DEVICE TO BE ON THE ATRIAL SEPTUM. THE MORNING OF (B)(6) 2011, THE PATIENT WENT FOR A JOG. THAT SAME DAY, A FOLLOW UP COMPUTED TOMOGRAPHY SCAN SHOWED THE HELEX DEVICE TO BE IN THE ABDOMINAL AORTA. ON (B)(6) 2011, THE DEVICE WAS EXPLANTED FROM THE AORTA WITH INTERVENTIONAL RETRIEVAL FORCEPS. THE PATIENT WAS DOING WELL FOLLOWING THE PROCEDURE AND WILL BE EVALUATED FOR DEVICE CLOSURE AT A LATER DATE.

N

Patient 1

A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING RECORDS VERIFIED THAT THE DEVICE MET ALL PRE-RELEASE SPECIFICATIONS.