FDA.reportPublic FDA data

MAUDE MDR 1878330

MDR report key
1878330
Report number
1057129-2010-00037
Event key
0
Event type
3
Date received
2010-10-14
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
MR. KENT IVERSEN
Address
15 DART ROAD NEWNAN GA 30265 US
Phone
678-678-6784
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1MEDPORMEDPOR CUSTOMIZED SURGICAL IMPLANTPOREX SURGICALJOFNA89020MCI-11509 E015C33HR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12010-10-1401. O

Event Narratives#

D

Patient 1

THE DOCTOR STATED THAT THE PT RECEIVED A MEDPOR FRONTAL CRANIAL IMPLANT. THE DOCTOR REPORTED THAT THE PT DEVELOPED A SHUNT INFECTION THAT LEAD TO THE REMOVAL OF THE IMPLANT. THE DOCTOR STATED THAT THERE WAS NO ISSUE WITH THE IMPLANT AND THE PT IS DOING FINE.

N

Patient 1

THE DEVICE HISTORY RECORDS FOR LOT NUMBER 89020-MCI-115-09 (B)(4) WAS REVIEWED AND ALL PROCESSING AND TEST CRITERIA ARE WITHIN THE MEPDOR IMPLANT SPECIFICATION.

D

Patient 1

AS REPORTED BY THE (B)(6) REGISTRY, APPROXIMATELY A MONTH POST INDEX PROCEDURE, THE PATIENT WAS DIAGNOSED WITH AN ISCHEMIC STROKE. EIGHT MONTHS POST-PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE PATIENT IS A AN (B)(6) FEMALE WHO WAS ENROLLED IN THE (B)(6) STUDY FOR STENTING OF THE OSTIUM OF THE RIGHT INTERNAL CAROTID ARTERY. THE INDEX PROCEDURE TOOK PLACE ON (B)(6) 2009. THE RATE OF STENOSIS IS 86%. AN ANGIOGUARD (601814RMC / LOT 70209537) DISTAL PROTECTION DEVICE WAS DEPLOYED DISTAL IN THE VESSEL AND THE LESION WAS PRE-DILATED. A PRECISE (PC0730RXC/ LOT 14003079) STENT WAS DEPLOYED IN THE LESION. THERE WAS NO MALFUNCTION WITH THE STENT. THE ANGIOGUARD WAS SUCCESSFULLY RETRIEVED. THERE WERE NO COMPLICATIONS DURING THE PROCEDURE. THE PATIENT WAS DISCHARGED THREE DAYS LATER. APPROXIMATELY ONE MONTH POST INDEX PROCEDURE, THE PATIENT EXPERIENCED HEMIPARESIS ON THE LEFT SIDE. ONSET WAS GRADUAL. DIAGNOSIS WAS A STROKE. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT. APPROXIMATELY EIGHT MONTHS POST PROCEDURE, THE PATIENT EXPIRED. THE CAUSE OF DEATH IS UNKNOWN. THE EVENT WAS EVALUATED AND DETERMINED TO BE UNRELATED TO THE INDEX PROCEDURE AND UNRELATED TO THE CORDIS PRODUCT.

N

Patient 1

THE DOCTOR REPORTED THAT THE PATIENT RECEIVED A MEDPOR CUSTOMIZED IMPLANT THAT DID NOT CONFORM WELL TO THE TEMPORAL REGIONS OF THE SKULL. THE DOCTOR STATED THAT HE TRIED TO MOLD/TRIM BUT THE POST OP APPEARANCE WAS NOT THAT PLEASANT. THE DOCTOR STATED THAT THERE IS A LARGE STEP OFF BETWEEN THE LATERAL EDGES AND THE CRANIUM BI TEMPORALLY. DEVICE NOT RETURNED