FDA Adverse Event Other Summary report: N

VENASEAL

MDR report key: 19511989 · Received June 10, 2024

Report

Report Number
MW5156116
Event Type
Other
Date Received
June 10, 2024
Date of Event
March 12, 2024
Report Date
June 6, 2024
Manufacturer
EV3, INC.
Product Code
PJQ
Adverse Event
Yes
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
IA, US
Reporter Occupation
PATIENT
Health Professional
*

Narratives

Description of Event or Problem · 0

I HAD A VEIN PROCEDURE DONE ON MY RIGHT GREATER SAPHENOUS VEIN DUE TO DEEP VENOUS INSUFFICIENCY. THE PROCEDURE WAS IDENTIFIED AS VENASEAL FROM THE MANUFACTURER, MEDTRONICS, INC. - WITHIN 3 DAYS, I BEGAN EXPERIENCING A SEVERE ALLERGIC REACTION, WHICH INCLUDED HIVES, EXTREME ITCHING TO THE POINT OF MY SKIN WAS BLEEDING AND LUNG DAMAGE. - I HAD ALLERGY TESTING DONE TO TEST MY SENSITIVITY TO THE CHEMICAL USED IN THE VENASEAL PROCEDURE, NAMELY CYANOACRYLATE. THIS CHEMICAL WAS INJECTED INTO MY RIGHT GREATER SAPHENOUS VEIN. I SAW AN ALLERGIST AND IT WAS CONFIRMED THAT I WAS EXTREMELY ALLERGIC TO CYANOACRYLATE. SINCE THIS CHEMICAL WAS IN MY BODY, THE REACTIONS CONTINUED FOR WELL OVER TWO MONTHS. IT WAS RECOMMENDED THAT I HAVE THE GREATER SAPHENOUS VEIN REMOVED SURGICALLY. I WAS ADMITTED TO THE HOSPITAL, (B)(6), IOWA ON (B)(6) 2024 FOR A RIGHT GREATER SAPHENOUS VEIN SAPHENECTOMY. I SPENT 1 NIGHT AS AN INPATIENT. I HAVE AN INCISION FROM MY ANKLE TO MY GROIN, WITH PERMANENT DISFIGURATION. I HAVE SUSTAINED PERMANENT DAMAGE TO MY LUNGS DUE TO THIS CHEMICAL. THE PROVIDERS ARE AS FOLLOWS: - (B)(6), VASCULAR SURGERY. THE (B)(6) - (B)(6), PA-C, VASCULAR SURGERY THE (B)(6), MEDTRONICS, INC. HAS SIMILAR DOCUMENTED CASES SUCH AS THIS. MY QUESTION, WHY IS ALLERGY PATCH TESTING DONE PRIOR TO THE VENASEAL PROCEDURE. I DON'T WANT ANY OTHER PATIENT TO HAVE TO GO THROUGH THIS. SINCERELY, (B)(6). POSITIVE ALLERGY PATCH TEST TO CYANOACRYLATE.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
766282 VENASEAL AGENT, OCCLUDING, VASCULAR, PERMANENT PJQ EV3, INC.

Patients

Seq Age Sex Outcome Treatment
1 64 YR Female Hospitalization| R| S| O