MAUDE Adverse Event Report: COOK INC NESTER PLATINUM EMBOLIZATION COIL; KRD DEVICE, EMBOLIZATION, VASCULAR

Model Number	N/A
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Nerve Damage (1979); Pain (1994); No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reporter occupation: esquire.Initial reporter also sent report to fda: unknown.Pma/510(k) #: preamendment.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported by a law firm, (patient) suffered from swelling of a vein resulting in pain and was diagnosed with pelvic congestion syndrome and pelvic venous varicosities as well as groin and back pain.On or about (b)(6) 2018, patient elected to have a varicocele embolization procedure during which cook nester embolization coils were implanted.Shortly after the procedure the patient allegedly began to experience a litany of health issues including ureter damage resulting in kidney and ovary auto-transplant, infections, depression; nerve damage, allergic reaction, left flank pain, and nutcracker phenomenon.The patient's doctor found that the embolization coils "eroded into the most gonadal veil into the ureter." on or about march 19, 2019, the patient had the coils removed due to "chronic pelvic and abdominal pain." after the coils were removed, the patient began to feel relief.Medical records indicated the following: on (b)(6) 2018, the patient underwent sotradecol embolization of pelvic vein varicosities and a coil and gelfoam embolization of the left canal vein due to severe pelvic pain with a markedly dilated left gonadal vein.An ultrasound was utilized to evaluate the right internal vein which was patent.A venogram of the left common iliac vein did not demonstrate evidence of may thurner syndrome.Left renal venograms demonstrated an enlarged refluxing left gonadal vein and multiple varicose veins.Next, per implant report, "the desiccation sheath was advanced into the jugular vein and the mpa catheter was advanced into the pelvis.Approximately 6 mm contrast filled the gonadal veins therefore 6 ml of foam sclerotherapy was administered into the pelvic varicose veins.This was followed by coil embolization of the left gonadal vein with 10 an 8 mm nester coils.A small amount of gelfoam was then administered and subsequent coil embolization of the venotomy was performed with six 8mm, two 10mm, and two 12mm nester coils.Subsequent venogram demonstrates occlusion of the vein therefore through the sheath a 12 mm amplatzer plug was successfully deployed 1 to 2 cm from the origin of the vessel.Final venogram demonstrated widely patent renal vein.No flow visualized in the left gonadal vein.The right collateral vein was selected as this vein is very small on multiple ct images and likely does not contribute to the patient's pelvic pain.The sheath was removed.Hemostasis obtained with manual pressure." some time after the procedure, the patient's coiling "became complicate by injury to the left ureter" and continued to have left flank pain.On an unknown date, the patient underwent a retrograde marcaine instillation test in her left kidney.The procedure improved her symptoms and confirmed diagnosis of altered anatomy with injury to the ureter.The patient was offered an auto-transplantation of her left kidney in an attempt to resolve her chronic pain issues as well as remove the foreign bodies and injured ureter.On (b)(6) 2019, the patient underwent a laparoscopic left nephroureterectomy with auto transplantation as well as removal of coils.During the procedure, the laparoscopic left nephroureterectomy was "at least 100% more difficult than the average laparoscopic nephroureterectomy due to (the patient's) previous gonadal vein coilings performed and several gi surgeries." the physician found "dense chronic scarring/adhesions and inflammatory tissue involving the renal arteries, vein, renal pelvis, ureter to the level of the bladder, thrombosed gonadal vein due to prior coiling procedure, and renal parenchyma" that required at least 2 hours longer operative time to complete this portion of the operation successfully and without complication.A gonadal vein resection and foreign body removal was conducted successfully along with kidney auto-transplant, ureterotomy with a ureteral implant and placement of open ureteral stent, and a left ovarian transposition and pexy to left lateral sidewall.Hemostasis was "perfect".The patient was taken to the pacu in stable condition.No other adverse effects were reported for this incident.The following are reports that capture different cook nester coils implanted into the patient in this event: medwatch report with patient identifier (b)(6)- lot #7838745, quantity 2 or 3, medwatch report with patient identifier (b)(6)- lot #,8045843, quantity 2, medwatch report with patient identifier (b)(6) - lot #7305115, quantity 1, medwatch report with patient identifier (b)(6) - lot #7493478, quantity 1, medwatch report with patient identifier (b)(6) - lot # 8062361, quantity 4 (this report).
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unchanged, unknown or unavailable.Investigation ¿ evaluation.A law firm reported an incident involving nester platinum embolization coils.On or around (b)(6) 2018, the patient had a varicocele embolization procedure.During the procedure, the patient had nester embolization coils implanted.Shortly after the procedure, the patient experienced multiple health issues including ureter damage resulting in kidney and ovary auto-transplant, infections, depression, nerve damage, allergic reaction, left flank pain, and nutcracker phenomenon.The doctor found the embolization coils implanted had eroded into the most gonadal veil into the ureter.The doctor suggested that the coils may be the cause of the pain and that they should be removed.On or about (b)(6) 2019, the patient had the coils removed due to chronic pelvic and abdominal pain.After the coils were removed, the patient began to feel relief.The patient had pre-existing conditions of pelvic congestion syndrome, pelvic vein varicosities, groin and back pain.The patient was advised the pain was due to swelling of a vein.Reviews of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control, and specifications of the device were conducted during the investigation.Additionally, a document based investigation evaluation was performed.The risks associated with these devices are acceptable when weighed against the benefits.Sufficient inspection activities are in place to identify potentially related failure modes prior to distribution.The device history record (dhr) for the complaint lot recorded no related non-conformances.A database search revealed no other complaints have been reported for the device lot.As there are adequate inspection activities established, objective evidence that the dhr was fully executed, no related non-conformances, and no additional complaints from the same lot, cook has concluded that there is no evidence that nonconforming product exists in house or in field.The product labeling was reviewed.The product ifu provides the following information to the user related to the reported failure mode: device description: "nester embolization coils are made of platinum with spaced synthetic fibers, and are supplied preloaded in a loading cartridge.They are designed to be delivered to the target vessel using a soft, straight wire guide through a standard angiographic catheter." warnings: "positioning of the embolization coils should be done with particular care.Coils should not be left too close to the inlets of arteries and should be intermeshed with previously placed coils if possible.A minimal but sufficient arterial blood flow should remain to hold the coils against the previously placed coils until a solid clot ensures permanent fixation.The purpose of these suggestions is to minimize the possibility of loose coils becoming dislodged and obstruction a normal and essential arterial channel." instructions for use: "perform a final angiogram to confirm the coil position within the target vessel." how supplied: "supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Avoid extended exposure to light.Upon removal from package, inspect the product to ensure no damage has occurred." a review of the design history file (dhf) showed that biocompatibility testing of nester coils has been completed as described in iso standards.The coil size and vessel size are unknown.It is possible that the coils were improperly sized or placed, leading to vessel protrusion, but this cannot be confirmed.It is also possible that the body's natural foreign body response contributed to the erosion.Based on the information provided, no returned product, and the results of the investigation, the investigation conclusion for this complaint is cause traced to a component failure without a manufacturing or design deficiency.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.

• Brand Name: NESTER PLATINUM EMBOLIZATION COIL
• Common Device Name: KRD DEVICE, EMBOLIZATION, VASCULAR
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11223136
• Report Number: 1820334-2021-00151
• Device Sequence Number: 3772367
• Product Code: KRD
• UDI-Device Identifier: 00827002269958
• UDI-Public: (01)00827002269958(17)220802(10)8062361
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/02/2022
• Device Model Number: N/A
• Device Catalogue Number: MWCE-35-14-8-NESTER
• Device Lot Number: 8062361
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 01/25/2021
• Supplement Report FDA Received Date: 03/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 2 14X10 COOK NESTER COILS; 2 14X12MM COOK NESTER COIL; 2 OR 3 ADDITIONAL 14X8MM COOK NESTER COILS; GELFOAM; ST. JUDE 12MM AMPLATZER CARDIOVASCULAR PLUG; UNKNOWN MANUFACTURER 21G MICROPUNCTURE NEEDLE; UNKNOWN MANUFACTURER 7 FR SHEATH; UNKNOWN MANUFACTURER DESICCATION SHEATH; UNKNOWN MANUFACTURER MPA CATHETER; 2 14X10 COOK NESTER COILS; 2 14X12MM COOK NESTER COIL; 2 OR 3 ADDITIONAL 14X8MM COOK NESTER COILS; GELFOAM; ST. JUDE 12MM AMPLATZER CARDIOVASCULAR PLUG; UNKNOWN MANUFACTURER 21G MICROPUNCTURE NEEDLE; UNKNOWN MANUFACTURER 7 FR SHEATH; UNKNOWN MANUFACTURER DESICCATION SHEATH; UNKNOWN MANUFACTURER MPA CATHETER
• Outcome Attributed to Adverse Event: Other; Required Intervention; Disability
• Patient Age: 34 YR