MAUDE Adverse Event Report: COOK, INC. NESTER EMBOLIZATION COILS; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number GA7356

Device Problem Migration (4003)

Patient Problems Nerve Damage (1979); Pain (1994); Hernia (2240); Sleep Dysfunction (2517); Abdominal Cramps (2543); Constipation (3274); Thrombosis/Thrombus (4440); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 04/16/2018

Event Type  Injury  

Event Description

I had a pelvic ovarian vein coil embolization surgery done with an interventional radiologist doctor in (b)(6) 2018 due to diagnosis of pelvic congestion syndrome and this was done to avoid any pelvic surgery.I had a lot of pain in the ovarian area after the insertion of the embolization coils for several days.My extreme symptoms and issues started 4-6 weeks following the coil embolization.In (b)(6) 2018 i had extreme pressure on my left-side lower pelvic and groin region, along with severe bowel issues, bladder issues, rectal pain and pressure and extreme insomnia.I called (b)(6) center in (b)(6) to complain about my symptoms and i was told to see my gastroenterologist doctor.The issues continued and only worsened from (b)(6) 2018 into 2019.So, in (b)(6) 2019, i was forced to have surgery to remove the uterus (hysterectomy) and 2 weeks following this surgery on saturday, (b)(6) 2019 i had to go to the emergency room with extreme pain on my left side into my left leg with no found cause.On (b)(6) 2019, 3.5 weeks after the hysterectomy surgery, i had a 6-cm localized blood clot that had to be removed during emergency surgery.Then, 5 months later in (b)(6) 2019, i had to remove my ovaries (oophorectomy) due to extreme pain and cramping in the ovarian pelvic region that radiated into both of my legs, predominantly on my left side.Continuing into (b)(6) 2019, i continued to have pain and that set-off a 27 month journey to diagnose and start to correct what damage was left behind from the embolization coils once they were removed.Please note, 1-2 embolization coils remain in my pelvis, in the retroperitoneal space within my iliac vein.As a result of the coils and their untold damage, i've endured 24-28 weeks of pelvic floor therapy, endless ct scans, ultrasounds, x-rays and mris, doctor appointments.I have seen 8 different types of surgeons for consultation or surgery as well to include: vascular surgeon, colorectal surgeon, hip surgeon, peripheral nerve surgeon, hernia surgeon, hernia and abdominal wall reconstruction surgeon, and 2 minimally invasive gyn surgeons (facog).In (b)(6) 2020, i had to have surgery to repair 2 femoral hernias, in a double femoral hernia repair surgery.These femoral hernias were a direct result of the embolization coils and the damage they can do to a human's body.Once the femoral hernias were repaired, my issues continued, with pelvic pain, back pain, shoulder pain and extreme issues with my bowel which has lead to chronic constipation symptoms over the last 4 years.Recently, in (b)(6) 2022 i saw a hernia and abdominal wall reconstruction surgeon due to not being able to identify the continuing pain all over my pelvis, down my left leg into my foot and up into my left rib cage.This new surgeon informed me that i have 3 nerve injuries, also called nerve entrapments or nerve compressions in my left-side pelvic, left-side abdominal and in my left-side sacroiliac joint region (behind my left hip).I was diagnosed with ilioinguinal nerve injury/compression, a iliohypogastric nerve injury/compression and a sacroiliac nerve injury/compression that also involves my left-side sacroiliac connective tendon.My left-side sacroiliac tendon is frayed as well and damaged.I am now pursuing nerve entrapment injections with a sports medicine doctor to help relieve the nerve compression, 3-4 injections will be done on each damaged nerve over a 3-4 month period to see if i can get relief.This process will take 3-4 months and endless doctor appts.If the nerve injury and entrapment cannot be resolved, i will have to have another 5th abdominal surgery following the coil surgery to correct the problem, which is a drastic step in cutting these specific nerves that are compressed to relieve my pain i've had for over 30+ months.Fda safety report id# (b)(4).

• Brand Name: NESTER EMBOLIZATION COILS
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): COOK, INC.
• MDR Report Key: 13862619
• MDR Text Key: 287888406
• Report Number: MW5108436
• Device Sequence Number: 1
• Product Code: KRD
• 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: 03/21/2022
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: GA7356
• Device Catalogue Number: MWCE-35-20-10-NESTER-01
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: ALLEGRA; FISH OIL; MULTI-VITAMIN; PROBIOTIC; SPIRONOLACTONE (50MG DAILY); VITAMIN C
• Patient Outcome(s): Disability; Other; Required Intervention
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White