FDA Adverse Event Injury Summary report: N

NEUROFORM EZ STENT SYSTEM

MDR report key: 7323176 · Received March 7, 2018

Report

Report Number
MW5075747
Event Type
Injury
Date Received
March 7, 2018
Date of Event
October 29, 2015
Report Date
March 6, 2018
Manufacturer
STRYKER NEUROVASCULAR
Product Code
NJE
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
FL, US
Reporter Occupation
PATIENT

Narratives

Description of Event or Problem · 1

NON-SURGEON DR. (B)(6) OF (B)(6) DID ANEURYSM REPAIR WITH NEUROFORM EZ STENT SYSTEM BY NEUROVASCULAR. HE USED 2 STENTS AND 7 COILS HAD STROKE IN PROCEDURE AND WAS IN ICU THEN READMITTED TO ICU WITH SEVERE PROBLEMS POST - HAD MANY HOSPITAL TRIPS AND SERIOUS PROBLEMS POST INCL. DAILY MIGRAINES, LOSS OF VISION, TIA (SEVERAL) DOUBLE VISION, VISION LOSS WITH HEAD MOVEMENT, AND REGULAR ANGIOS TO MAKE SURE NO MOVEMENT BY NEW DOCTOR - TOP SURGEON. IT TOOK US OVER 2 YEARS AND AN ATTORNEY CALLING DOCTOR TO GET INFO ON WHAT HE USED AS HE REFUSED TO SUPPLY AND WAS NOT IN HOSPITAL NOTES - NOTE SURGEON WAS TO DO PROCEDURE WE WERE PROMISED BY NON SURGEON DID - NOW PERMANENTLY DISABLED AND NEED WALKER AND HELP WITH DAILY TASKS. THIS SYSTEM CANNOT BE REMOVED, AND MY LIFE IS NOW ONE IN GED AND MUCH PAIN AND DISABILITY. HOW THIS DEVICE EVER CLEARED BY YOUR OFFICE FOR USE IS ASTONISHING - GOING TO PRESS AND (B)(6) FOR HELP - THIS NEEDS TO BE PULLED AS BROCHURE FINALLY RECEIVED OVER 2 YEARS POST SAYS STUDY OF 30 PTS 2 DIED AND MANY SERIOUS COMPLICATIONS! THIS IS NOT OK - OTHER DOCS - NEUROSURGEONS WILL NOT USE THIS DUE TO AWFUL SIDE EFFECTS INCLUDING DEATH AND PERM DISABILITY LIKE ME. HOW DO YOU ALLOW A NON-SURGEON TO DO THIS PROCEDURE AND ALLOW THIS DEVICE TO BE AVAILABLE? AWAITING RESPONSE. DEVICE STILL IN HEAD, UNABLE TO REMOVE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
163443 NEUROFORM EZ STENT SYSTEM NEUROFORM EZ STENT SYSTEM NJE STRYKER NEUROVASCULAR

Patients

Seq Age Sex Outcome Treatment
1 51 YR Hospitalization| L| R| S