FDA Adverse Event Death Summary report: N

EXCELSIOR SL10 MICROCATHETER

MDR report key: 4976017 · Received July 31, 2015

Report

Report Number
MW5045142
Event Type
Death
Date Received
July 31, 2015
Date of Event
April 13, 2015
Report Date
June 19, 2015
Manufacturer
STRYKER NEUROVASCULAR
Product Code
DQY
Adverse Event
Yes
Report Source
Voluntary report
Reporter Occupation
0

Narratives

Description of Event or Problem · 0

FINDINGS: THIS PATIENT WAS A (B)(6) YEARS OLD WOMAN WHO WAS REFERRED TO DR (B)(6) FOR ENDOVASCULAR TREATMENT OF A 9MM BASILAR TIP ANEURYSM. THE INTENT WAS TO DO STENT ASSISTED COILING. THIS PATIENT HAD PRIOR HISTORY OF COPD AND LUNG CANCER WITH LONG TERM SURVIVAL EXPECTATION. THE PATIENT WAS PREMEDICATED WITH PLAVIX AND ASPIRIN PRIOR TO THE PROCEDURE AND WAS ANTICOAGULATED DURING THE PROCEDURE FOR STENT ASSISTED COILING. DURING PLACEMENT OF A MICROCATHETER (FOR ACCESS FOR STENT PLACEMENT) BUT PRIOR TO STENT DEPLOYMENT THE ANEURYSM RUPTURE. (THE OPERATOR INDICATES THAT THE MICROCATHETER AND WIRE WERE NOT IN THE ANEURYSM. THERE WAS NOTHING UNUSUAL ABOUT THESE DEVICES.) THE OPERATOR (DR (B)(6)) REVERSED THE HEPARIN WITH PROTAMINE AND PERFORMED A STENT ASSISTED COILING. DURING THIS TIME BLOOD FLOW TO THE POSTERIOR FOSSA WAS NOT DETECTED (INTRACRANIAL PRESSURE EXCEEDING BLOOD PRESSURE). DR (B)(6) WAS CALLED FOR EMERGENT PLACEMENT OF A VENTRICULOSTOMY. AFTER THE PROCEDURE WAS COMPLETED, IT WAS NOTED ON CT AND MRI THAT THERE WAS EXTENSIVE SUBARACHNOID HEMORRHAGE AND BRAIN DAMAGE. THE PATIENT WAS DISCHARGED TO HOSPICE 11 DAYS LATER AND SUBSEQUENTLY EXPIRED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
501618 EXCELSIOR SL10 MICROCATHETER CATHETER DQY STRYKER NEUROVASCULAR 18038597
501619 SYNCHRO2 0.14 MICROWIRE (STRYKER) MICROWIRE DQX STRYKER NEUROVASCULAR B36048

Patients

Seq Age Sex Outcome Treatment
0 69 YR Death| H| O