UNKNOWN
Report
- Report Number
- 1820334-2020-02048
- Event Type
- Injury
- Date Received
- November 6, 2020
- Report Date
- March 24, 2021
- Manufacturer
- COOK INC
- Product Code
- KRD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.
INVESTIGATION ¿ EVALUATION. A LAW FIRM REPORTED AN INCIDENT INVOLVING NESTER AND TORNADO EMBOLIZATION COILS. ON OR AROUND (B)(6) 2020 A PATIENT HAD A VARICOCELE EMBOLIZATION PROCEDURE OF THE LEFT GONADAL VEIN AND LEFT PELVIC VARICES. DURING THE PROCEDURE, THE PATIENT HAD SEVERAL NESTER AND TORNADO EMBOLIZATION COILS IMPLANTED. THE NESTER COILS ARE INVESTIGATED IN THIS COMPLAINT, AND THE TORNADO COILS ARE INVESTIGATED UNDER MEDWATCH REPORT #1820334-2020-02051. ALL COILS ARE FROM UNKNOWN LOT NUMBERS. SHORTLY, AFTER THE PROCEDURE, THE PATIENT EXPERIENCED MULTIPLE HEALTH ISSUES INCLUDING INCREASED ABDOMINAL PAIN AND PRESSURE, INCREASED BACK PAIN, AND PELVIC PAIN. ON OR AROUND (B)(6) 2019, THE PATIENT HAD THE COILS REMOVED DUE TO THE CHRONIC PELVIC AND ABDOMINAL PAIN. AFTER THE COILS WERE REMOVED, THE PATIENT BEGAN TO FEEL SOME RELIEF. THE PATIENT HAD PRE-EXISTING CONDITIONS OF PELVIC CONGESTION SYNDROME AND PELVIC VENOUS VARICES. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINANT DID NOT RETURN THE COMPLAINT DEVICE TO COOK FOR INVESTIGATION. DUE TO THIS, NO DIMENSIONAL, VISUAL, OR FUNCTIONAL VERIFICATIONS COULD BE COMPLETED. THERE IS NO EVIDENCE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. 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) COULD NOT BE REVIEWED DUE TO LACK OF LOT INFORMATION. HOWEVER, COOK WAS INFORMED OF FACILITIES INVOLVED IN THE CASE. IT IS UNKNOWN WHICH FACILITY OR IF THESE FACILITIES ARE WHERE THE COILS WERE IMPLANTED. A GLOBAL SALES SHIPMENT REPORT WAS CONDUCTED FROM (B)(6) 2017 THROUGH (B)(6) 2020 FOR NESTER COILS. COOK WAS UNABLE TO NARROW DOWN THE LOT THIS COMPLAINT PERTAINS TO. THERE IS NO EVIDENCE SUGGESTING NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE 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. A DEFINITIVE CONCLUSION COULD NOT BE DETERMINED WHY THE PATIENT EXPERIENCED AN ADVERSE PHYSIOLOGICAL RESPONSE. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, THE INVESTIGATION CONCLUSION FOR THIS COMPLAINT IS CAUSE TRACED TO THE PATIENT FOR AN ADVERSE PHYSIOLOGICAL RESPONSE. 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.
PER MEDICAL RECORDS RECEIVED 07JAN2021: "PROCEDURE: INFORMED CONSENT WAS OBTAINED THE PATIENT WAS GIVEN PROPHYLACTIC ANTIBIOTIC AND INTRAVENOUS SEDATION. THE RIGHT NECK WAS PREPPED AND DRAPED STERILELY. LOCAL ANESTHETIC WAS GIVEN. ACCESS WAS GAIN INTO THE RIGHT INTERNAL JUGULAR VEIN WITH A 7 FRENCH SHEATH. A COMBINATION OF MULTIPURPOSE CATHETERS WAS USED TO SELECTIVELY CATHETERIZE BOTH OVARIAN VEINS. RETROGRADE VENOGRAPHY WAS OBTAINED, CONFIRMING THE PRESENCE OF VALVULAR INSUFFICIENCY OF BOTH OVARIAN VEINS AND FORMATION OF LARGE PELVIC VARICES, LEFT GREATER THAN RIGHT. CLOSURE OF BOTH OVARIAN VEINS WAS ACCOMPLISHED WITH A COMBINATION OF SOTRADECOL FOAM SCLEROTHERAPY, COILS AND A SMALL AMOUNT OF ABSOLUTE ETHANOL. NO IMMEDIATE COMPLICATIONS WERE ENCOUNTERED. THE SHEATH WAS REMOVED AND HEMOSTASIS OBTAINED WITH MANUAL PRESSURE. CONCLUSION: VALVULAR INSUFFICIENCY OF BILATERAL OVARIAN VEINS WITH FORMATION WITH LARGE PELVIC VARICES. SCLEROTHERAPY AND COIL OCCLUSION OF BOTH OVARIAN VEINS."
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
SUSPECT MEDICAL DEVICE: UNKNOWN NESTER EMBOLIZATION COILS OR MICROCOILS. INITIAL REPORTER OCCUPATION: ESQUIRE. PMA/510(K) #: EXACT DEVICE IDENTITY IS NOT KNOWN. DEVICE IS PREAMENDMENT OR K153778. (B)(4). THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED, (PATIENT) SUFFERED FROM SWELLING OF A VEIN RESULTING IN PAIN AND WAS DIAGNOSED WITH PELVIC CONGESTION SYNDROME AND PELVIC VENOUS VARICES. ON OR ABOUT (B)(6) 2012, PATIENT ELECTED TO HAVE A VARICOCELE EMBOLIZATION PROCEDURE OF THE LEFT GONADAL VEIN AND LEFT PELVIC VARICES DURING WHICH SEVERAL COOK NESTER AND TORNADO EMBOLIZATION COILS WERE IMPLANTED. SHORTLY AFTER THE PROCEDURE THE PATIENT ALLEGEDLY BEGAN TO EXPERIENCE A LITANY OF HEALTH ISSUES INCLUDING INCREASED ABDOMINAL PAIN AND PRESSURE, INCREASED BACK PAIN, AND PELVIC PAIN. 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 SOME RELIEF. NO OTHER ADVERSE EFFECTS WERE REPORTED. ADDITIONAL INFORMATION IS UNAVAILABLE AT THIS TIME. THE NESTER COILS INVOLVED IN THIS CASE ARE RECORDED UNDER THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6). THE TORNADO COILS INVOLVED IN THIS CASE ARE RECORDED UNDER THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1264733 | UNKNOWN | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Required Intervention | COOK TORNADO COILS| UNKNOWN MANUFACTURER 7 FR SHEATH| UNKNOWN MANUFACTURER MULTIPURPOSE CATHETERS| UNKNOWN MANUFACTURER SOTRADECOL FOAM |