MAUDE Adverse Event Report: MEDTRONIC, INC. VENASEAL; AGENT, OCCLUDING, VASCULAR, PERMANENT

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Pain (1994); Swelling (2091); Thrombus (2101); Reaction (2414); Caustic/Chemical Burns (2549)

Event Date 05/05/2017

Event Type  Injury  

Event Description

I am sharing my ongoing negative experience with this product and debilitating adverse side effects.If you have a reaction, once you have glue in your system, you will go through excruciating hell to have it removed.A simple allergy patch test would have avoided this ordeal.Of course big companies are protected from liability even though their procedure fails to eliminate possible adverse reactions prior to administering this product.If i can help one person not have to go through this horrible nightmare, it is worth the pain i've endured.(please share) this has been life changing, painful, debilitating and financially paralyzing for my family and me.I am a healthy (b)(6) year old woman with zero medical issues.(b)(6) 2016, my left calf began to swell, i thought it was from hitting it with a heavy object.After seeking medical advice from urgent care, er specialist, i was sent to (b)(6) vein specialists in (b)(6).(b)(6) 2017, dr.(b)(6) did extensive ultrasounds determining i had a leaky vein, very common with swelling in the lower left leg.I had to continue wearing a compression stocking for 2 months for "insurance protocol" before undergoing a procedure to close off my vein.Initially, i opted to have my leg cauterized until i received a call from dr.(b)(6)' nurse convincing me to participate in a trial study for venaseal glue.I was told this was the less invasive route, less risk of infection, blood clots, reopening vein and less money because (b)(6) wanted my $(b)(6) deductible up front.The nurse went on to say if she were going through this, this is the route she would take.(b)(6) 2017, dr.(b)(6) at (b)(6) closed off a vein in my upper and lower leg which branched off to smaller capillaries, within 48 hours after my procedure, my leg flared up bright red and hot and i knew something was wrong.Multiple appointments over months in severe pain, swelling and daily ibuprofen (recently diagnosed as stomach ulcers through endoscopy) after 10 months i was finally able to convince dr.(b)(6) there was something significantly wrong with my leg.At this point, my leg was much worse than it was prior to having it closed off with glue.Dr.(b)(6) ordered an allergy test at (b)(6), my back lit up on fire where glue had been applied.Two weeks later, dr.(b)(6), vascular surgeon in (b)(6), surgically removed an 18-inch vein from my upper leg to my lower then went on to remove glue from my lower leg that branched off into smaller capillaries to the best of his ability.I feared my lower leg would have issues with glue particles since it wasn't able to be removed as one whole piece like my upper vein in a stripped fashion.Immediately, a 1 inch section of my incision wasn't healing like the rest of the 4.5-inch incision.There seemed to be something festering in two areas that bulged.I was able to extract 2 slivers of glue that came to a head in my incision.I went back to see dr.(b)(6) who determined we would need to remove a huge chunk of tissue as our best attempt to get remaining glue out.Dr.(b)(6) felt this was aggressive and thought we should attempt removing glue in his office from the surface.It was confirmed through pathology, there was more glue in my leg.(b)(6) 2018, i had a third attempt and second surgery to remove glue.Dr.(b)(6)'s plan was to remove 4 inches long by 1 inch and deep to be sure all glue was removed once and for all.As i sit here recovering from a (hot dog bun size) 6 plus inch incision, more than an inch wide with more flesh removed internally to the bone, i am certain what dr.(b)(6) found was not good.I am waiting for my follow up appointment and pathology reports from this procedure.I am angry, this didn't need to happen.I'm frustrated venaseal has zero liability for the damage caused and suffering not only myself but my family have had to endure.A simple patch test prior for all patients to ensure they will not have a reaction is a simple solution.Dates of use: (b)(6) 2017 - (b)(6) 2018.Diagnosis or reason for use: varicose vein."is the product compounded:yes; is the product over-the-counter: no." http://medtronicendovenous.Com/p.

• Brand Name: VENASEAL
• Type of Device: AGENT, OCCLUDING, VASCULAR, PERMANENT
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 7645679
• MDR Text Key: 112849861
• Report Number: MW5078127
• Device Sequence Number: 1
• Product Code: PJQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 50 YR
• Patient Weight: 82