FDA Adverse Event Death Summary report: N

HDE GATEWAY

MDR report key: 4925168 · Received July 14, 2015

Report

Report Number
MW5044439
Event Type
Death
Date Received
July 14, 2015
Date of Event
July 11, 2015
Report Date
July 14, 2015
Manufacturer
STRYKER
Product Code
NJE
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
TN, US
Reporter Occupation
NURSE

Narratives

Description of Event or Problem · 1

ON (B)(6) 2015, (B)(6), WAS TRANSFERRED TO OUR FACILITY WITH A SUBARACHNOID HEMORRHAGE. HUNT AND HESS GRADE II, RELATED TO A RUPTURED BASILAR TIP ANEURYSM. (B)(6) WAS TAKEN TO THE NEURO-IVR SUITE. A CEREBRAL ANGIOGRAM REVEALED AN IRREGULAR BASILAR TIP ANEURYSM WITH A PSEUDOANEURYSM. AFTER PLACEMENT OF THE COILS THERE WAS PROGRESSIVE OCCLUSION OF THE ANEURYSM. IT WAS NOTED THROMBUS WAS PRESENT AT THE PCA ORIGIN. SMALL AMOUNT OF THROMBUS WAS PRESENT IN THE LEFT ICA. 5.6ML OF INTEGRILIN WAS GIVEN INTRA-ARTERIALLY SLOWLY BY THE INTERVENTIONIST. AFTER THE INFUSION WAS COMPLETE, THE LEFT ICA WAS WIDELY PATENT. THERE WAS A PERSISTENT FILLING DEFECT SUGGESTIVE OF PERSISTENT CLOT AT THE RIGHT PI ORIGIN. IT WAS FELT THAT IF IMMEDIATE INTERVENTION WAS NOT PERFORMED THE PT WOULD BE AT GREAT RISK FOR COMPLICATIONS INCLUDING STROKE. THE HDE GATEWAY BALLOON CATHETER IS SMALLER THAN LARGER COMMERCIAL BALLOONS AND WAS SPECIALLY DESIGNED FOR CEREBRAL ARTERIES. WITH THE PROGRESSIVE NARROWING OF THE NEAR OCCLUSION THERE WAS NOT ENOUGH TIME TO CONSULT WITH ANOTHER PHYSICIAN OR THE IRB. ANGIOPLASTY WAS PERFORMED USING THE GATEWAY BALLOON. AFTER THE ANGIOPLASTY WAS DONE, MINIMAL RESIDUAL CLOT IS NOTED IN THE DISTAL PCA WITHOUT FLOW LIMITATION AND THE PROXIMAL CLOT WAS RESOLVED. PT WAS TRANSFERRED TO NICU IN GUARDED CONDITION. THE PHYSICIAN TALKED WITH ANOTHER PHYSICIAN AFTER THE CASE AND HE CONCURRED WITH THE USAGE OF THE DEVICE FOR CLOT DISRUPTION. THE USE OF THE HDE DEVICE WAS REPORTED TO OUR LOCAL IRB. PT, (B)(6), SLOWLY WAS IMPROVING OVER THE NEXT COUPLE OF DAYS. ON (B)(6) 2015, HE HAD SOME CONFUSION, CT SCAN SHOWED SAH AND IV BLOOD AND POSSIBLE HYDROCEPHALY. NEUROSURGERY WAS CONSULTED, WOULD CONTINUE TO MONITOR. ON (B)(6) 2015, AT 17:30, PT WAS HALLUCINATING AND INCREASED RESTLESSNESS, AND WAS MEDICATED. AT 21:00 HE BECAME LESS RESPONSIVE. CT SCAN WAS REPEATED AND NEUROSURGERY PREPARED FOR VENTRICULOSTOMY AT BEDSIDE. AT 21:45, PT RESPIRATORY ARRESTED AND WAS INTUBATED, AND CODED, PT DIED AT 22:43. EXACT CAUSE OF DEATH IS UNK AT THIS TIME.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
457922 HDE GATEWAY ANGIOPLASTY BALLOON CATHETER NJE STRYKER 17022074

Patients

Seq Age Sex Outcome Treatment
1 55 YR Death| O TARGET 360 ULTRA 3MMX6CM (DEPLOYED)| STRYKER COILS: TARGET XL 360 STANDARD 8MMX30CM| TARGET 360 ULTRA 3MMX6CM (DEPLOYED)| TARGET 360 STANDARD 8MMX20CM (DEPLOYED)| SYNCHRO2 SOFT WIRE| ACESSORY DEVICES: CODMAN MPD 6F| STRYKER EXCLESIOR SL-10 MICROCATHETER| (NOT DEPLOYED), COULD NOT FIT SAFELY| TARGET 360 ULTRA 3MMX4CM (DEPLOYED)