FDA.reportPublic FDA data

MAUDE MDR 5564667

MDR report key
5564667
Report number
3008853977-2016-00128
Event key
0
Event type
3
Date of event
2013-09-01
Date received
2016-04-08
Adverse event
3
Product problem
0
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. SANDA DRACIC
Address
47900 BAYSIDE PARKWAY FREMONT CA 94538 US
Phone
510-510-5104
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
0UNKNOWN_NEUROVASCULAR_PRODUCTCATHETER, BALLOON TYPEBOSTON SCIENTIFIC - MINNPAVUNK_NEUUNKNOWNR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-04-0801. D; 2. O

Event Narratives#

N

Patient 1

THE EXACT DATE OF THE ADVERSE EVENT IS UNKNOWN. ALL PATIENTS WERE TREATED BETWEEN (B)(6) 2013 AND (B)(6) 2015. THIS REPORT IS 2 OF 2 COVERING BALLOON TREATED PATIENTS THAT EXPERIENCED STROKES, TRANSIENT ISCHEMIC ATTACKS AND DEATH. THE SUBJECT DEVICE IS NOT AVAILABLE.

D

Patient 1

THE STROKE JOURNAL DOCUMENTED THE RESULTS OF A THIRTY-DAY OUTCOME OF A MULTICENTER REGISTRY STUDY OF STENTING FOR SYMPTOMATIC INTRACRANIAL ARTERY STENOSIS. THE ARTICLE INFORMED THAT 141 PATIENTS WERE TREATED WITH THE BALLOON (SUBJECT DEVICE) PRE-DILATION PLUS SELF-EXPANDING STENTING. OF THE PATIENTS TREATED, 6 PATIENTS HAD A 30 DAYS PRIMARY END POINTS OF STROKE, TRANSIENT ISCHEMIC ATTACK, AND DEATH. IN ADDITION, 6 PATIENTS HAD SECONDARY END POINTS OF UNSUCCESSFUL REVASCULARIZATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

N

Patient 1

A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT REPORTED. THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. HOWEVER, TRANSIENT ISCHEMIC ATTACK(TIA), STROKE AND DEATH ARE KNOWN RISKS ASSOCIATED WITH ENDOVASCULAR PROCEDURES AND ARE LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE (DFU). THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATIONS WAS ASSIGNED TO THIS EVENT.

D

Patient 1

THE STROKE JOURNAL DOCUMENTED THE RESULTS OF A THIRTY-DAY OUTCOME OF A MULTICENTER REGISTRY STUDY OF STENTING FOR SYMPTOMATIC INTRACRANIAL ARTERY STENOSIS. THE ARTICLE INFORMED THAT 141 PATIENTS WERE TREATED WITH THE BALLOON (SUBJECT DEVICE) PRE-DILATION PLUS SELF-EXPANDING STENTING. OF THE PATIENTS TREATED, 6 PATIENTS HAD A 30 DAYS PRIMARY END POINTS OF STROKE, TRANSIENT ISCHEMIC ATTACK, AND DEATH. IN ADDITION, 6 PATIENTS HAD SECONDARY END POINTS OF UNSUCCESSFUL REVASCULARIZATION. IT WAS NOT POSSIBLE TO ASCERTAIN SPECIFIC DEVICE OR PATIENT INFORMATION FROM THE ARTICLE, OR TO MATCH THE EVENTS REPORTED WITH PREVIOUSLY REPORTED COMPLAINTS. NO ADDITIONAL INFORMATION IS AVAILABLE.