NESTER PLATINUM EMBOLIZATION COIL
Report
- Report Number
- 1820334-2020-01128
- Event Type
- Injury
- Date Received
- June 14, 2020
- Report Date
- January 20, 2021
- Manufacturer
- COOK INC
- Product Code
- KRD
- PMA / PMN Number
- K153778
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN, OR UNAVAILABLE. ADDITIONAL INFORMATION: SECTION C, D1, D4, D11 D11-- ADDITIONAL CONCOMITANT PRODUCT: LAKE REGIONAL MEDICAL STARTER GUIDEWIRE 0.035 IN X 180 CM INVESTIGATION ¿ EVALUATION ADDITIONAL INFORMATION RECEIVED 12OCT2020 PROVIDED THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICE. THEREFORE, THE INVESTIGATION WAS REOPENED TO INCLUDE THE ADDITIONAL INFORMATION. A REVIEW OF THE COMPLAINT HISTORY AND DEVICE HISTORY RECORD WERE CONDUCTED TO SUPPLEMENT THE PREVIOUS INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS ALSO CONDUCTED AS A PART OF THE INVESTIGATION TO CHECK FOR FAILURE RELATED NONCONFORMANCES AND ADDITIONAL COMPLAINTS. THE DHR FOR THE COMPLAINT LOT SHOWED NO RELATED NONCONFORMANCES. A DATABASE SEARCH REVEALED NO OTHER COMPLAINTS FROM THE LOT AT THE TIME OF INVESTIGATION. SINCE THERE ARE NO RELATED NONCONFORMANCES OR OTHER COMPLAINTS FROM THIS LOT, THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. FINDINGS OF THIS INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. IT IS POSSIBLE THE PATIENT IS ALLERGIC TO THE MATERIALS OF THE COIL. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT FOR INSPECTION, AND RESULTS OF THE INVESTIGATION, THE CAUSE WAS TRACED TO THE PATIENT FOR AN ADVERSE PHYSIOLOGICAL RESPONSE. 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.
BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: SECTION C INVESTIGATION ¿ EVALUATION A REPRESENTATIVE FROM A LAW FIRM INFORMED COOK OF AN INCIDENT INVOLVING A NESTER EMBOLIZATION COIL. SOMETIME IN (B)(6) 2017, A PATIENT BEGAN HAVING PAIN IN HIS SCROTUM. OVER THE NEXT YEAR THE PAIN WORSENED. AROUND (B)(6) 2018, THE DOCTOR RECOMMENDED A VARICOCELE PROCEDURE. AROUND (B)(6) 2018 DURING A VARICOCELE EMBOLIZATION PROCEDURE, NESTER COILS WERE IMPLANTED. AFTER THE PROCEDURE, THE PATIENT BEGAN EXPERIENCING HEALTH ISSUES, INCLUDING BLOOD CLOTS, CONTINUOUS ABDOMINAL CRAMPS, EXCRUCIATING ABDOMINAL PAIN, ANXIETY, CHRONIC BOWEL AND DIGESTIVE ISSUE, AND METAL ALLERGIC REACTIONS. THE DOCTOR WAS UNABLE TO RELATE THE NESTER COILS TO THE PATIENT¿S HEALTH ISSUES. THEREFORE, THE PATIENT FOUND A NEW DOCTOR WHO RECOMMENDED REMOVING THE COILS. THE DOCTOR SUSPECTED HE MAY BE HAVING A METAL ALLERGY. AROUND (B)(6) 2019, THE DOCTOR REMOVED THE COILS DURING A LAPAROSCOPIC EMBOLIZATION COIL REMOVAL. AFTER REMOVAL OF THE COILS, THE PATIENT BEGAN TO FEEL RELIEF. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED. THEREFORE, NO VISUAL INSPECTION OF THE DEVICE WAS COMPLETED. HOWEVER, 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 NONCONFORMING DEVICES PRIOR TO DISTRIBUTION. A REVIEW OF THE DESIGN HISTORY FILE SHOWED THAT BIOCOMPATIBILITY TESTING OF NESTER COILS HAS BEEN COMPLETED AS DESCRIBED IN ISO STANDARDS. THE INSTRUCTIONS FOR USE (IFU) PACKED WITH THE DEVICE WAS REVIEWED FOR RELEVANT INFORMATION RELATED TO THE REPORTED FAILURE MODE. THE IFU RELEVANT INFORMATION STATES: 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." THE DEVICE HISTORY RECORD (DHR) COULD NOT BE COMPLETED DUE TO LACK OF LOT INFORMATION FROM THE USER FACILITY. COOK WAS ONLY INFORMED OF THE DOCTOR¿S INVOLVED IN THE LAWSUIT. THE NAME OF THE FACILITY HAS NOT BEEN PROVIDED. THEREFORE, COOK IS UNABLE TO CONDUCT A GLOBAL SALES SHIPMENT REPORT TO ATTEMPT TO FIND THE LOT NUMBER. FINDINGS OF THIS INVESTIGATION REVEALED NO EVIDENCE TO SUGGEST THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. IT IS POSSIBLE THE PATIENT IS ALLERGIC TO THE MATERIALS OF THE COIL. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT FOR INSPECTION, AND RESULTS OF THE INVESTIGATION, THE CAUSE WAS TRACED TO THE PATIENT FOR AN ADVERSE PHYSIOLOGICAL RESPONSE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.
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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
PATIENT MEDICAL RECORDS WERE RECEIVED ON 07JAN2021 AND DESCRIBES THE IMPLANT PROCEDURE AS FOLLOWS: "AFTER OBTAINING INFORMED CONSENT, THE PATIENT WAS BROUGHT TO THE ANGIOGRAPHY SUITE AND PLACED ON THE ANGIOGRAPHY TABLE IN SUPINE POSITION. BOTH GROINS WERE PREPPED AND DRAPED IN TYPICAL STERILE FASHION. LOCAL ANESTHESIA WAS ACHIEVED UTILIZING 1% LIDOCAINE AND LEVEL II INTRAVENOUS CONSCIOUS SEDATION WAS ADMINISTERED AND MAINTAINED THROUGHOUT THE ENTIRE PROCEDURE FOR APPROXIMATELY ONE HOUR. APPROPRIATE MONITORING WAS MAINTAINED THROUGHOUT THE ENTIRE PROCEDURE AND DURING THE POST-PROCEDURE RECOVERY PERIOD. A TIMEOUT WAS PERFORMED PRIOR TO THE START OF THE PROCEDURE IN ORDER TO CONFIRM PATIENT IDENTITY AND PROCEDURE LOCATION. US WAS USED TO INTERROGATE THE RIGHT COMMON FEMORAL VEIN PRIOR TO ACCESSING IT AND IT WAS FOUND TO BE WIDELY PATENT. AN IMAGE OF THE ACCESS SITE WAS STORED FOR DOCUMENTATION. PUNCTURE OF THE RIGHT COMMON FEMORAL VEIN WAS THEN PERFORMED USING A MICROPUNCTURE NEEDLE. THE NEEDLE WAS THEN EXCHANGED OVER A WIRE UNDER FLUOROSCOPIC MONITORING FOR A 5 FRENCH VASCULAR SHEATH. THROUGH THE SHEATH AND OVER A WIRE, A 4 FRENCH COBRA CATHETER WAS USED FOR CATHETERIZATION OF THE LEFT RENAL VEIN. LEFT RENAL VENOGRAPHY WAS THEN PERFORMED SHOWING NO ANATOMIC VARIATIONS OR ABNORMALITIES. THE ORIGIN OF THE LEFT GONADAL VEIN WAS IDENTIFIED. USING FLUOROSCOPIC ROAD MAPPING TECHNIQUE, THE LEFT GONADAL VEIN WAS CATHETERIZED USING THE 4 FRENCH COBRA CATHETER. LEFT GONADAL VENOGRAPHY WAS THEN PERFORMED SHOWING THE CATHETER TO BE IN GOOD POSITION WITHIN THE CENTRAL PORTION OF THE LEFT GONADAL VEIN WITH DOCUMENTED REFLUX IN THE LEFT GONADAL VEIN CONSISTENT WITH THE CLINICAL HISTORY OF LEFT SIDED VARICOCELE. THE COBRA CATHETER WAS ADVANCED TO THE DISTAL GONADAL VEIN AND A REPEAT VENOGRAM WAS PERFORMED. UPON CONFIRMATION OF ADEQUATE CATHETER POSITION AND REFLUX WITHIN THE VESSEL, WE BEGAN THE EMBOLIZATION PORTION OF THE EXAMINATION. THE EMBOLIZATION WAS PERFORMED USING A COMBINATION OF NESTER EMBOLIZATION COIL AND 1% FOAMED SOTREDECOL SCLEROTHER PY. THE COIL USED WAS 0.035, 8 MM DIAMETER COIL WITH AN NON-DEPLOYED LENGTH OF 7 CM. WE INITIALLY PLACED TWO COILS IN THE PERIPHERAL PORTION OF THE LEFT GONADAL VEIN AND CONFIRMED ACCURATE PLACEMENT WITH POST EMBOLIZATION VENOGRAPHY WITHIN THE LEFT GONADAL VEIN. THIS SHOWED NO FLOW OF CONTRAST PERIPHERAL TO THE COILS IN KEEPING WITH GOOD EMBOLIZATION. WE SUBSEQUENTLY RETRACTED THE CATHETERS TO THE LEVEL OF THE ILIAC CREST AND PERFORMED A CONTROLLED INJECTION TO DETERMINE THE VOLUME OF SOLUTION NECESSARY TO FILL THE LEFT GONADAL VEIN SEGMENT INFERIOR TO THE CATHETER AND THE SMALL COLLATERAL VESSELS IN THE AREA. THE APPROPRIATE VOLUME OF FOAMED SOTREDECOL WAS THEN INJECTED UNDER FLUOROSCOPIC MONITORING. THE CATHETER WAS AGAIN RETRACTED TO THE LEVEL OF THE CENTRAL LEFT GONADAL VEIN. AGAIN, A CONTROLLED VENOGRAM WAS PERFORMED FOR CALCULATION OF VOLUME AND THE APPROPRIATE VOLUME OF FOAMED SOTREDECOL WAS INJECTED UNDER FLUOROSCOPIC MONITORING. FINALLY, A SECOND NESTER EMBOLIZATION COIL WAS PLACED IN THE CENTRAL PORTION OF THE LEFT GONADAL VEIN. A FINAL POST-EMBOLIZATION VENOGRAM WAS PERFORMED WITHIN THE LEFT RENAL VEIN SHOWING NO FLOW WITHIN THE LEFT GONADAL VEIN. ATTEMPTS WERE MADE TO CATHETERIZE THE RIGHT GONADAL VEIN USING A SIMMONS CATHETER, HK1 CATHETER AND COBRA CATHETER WITHOUT SUCCESS. ALL CATHETERS, WIRES AND SHEATHS WERE THEN REMOVED AND HEMOSTASIS ACHIEVED AT THE RIGHT GROIN BY MANUAL COMPRESSION. A DRY DRESSING WAS APPLIED AT THE INITIAL PUNCTURE SITE. THE PATIENT TOLERATED THE PROCEDURE WELL AND THERE WERE NO COMPLICATIONS. IMPRESSION: SUCCESSFUL, UNCOMPLICATED EMBOLIZATION OF THE LEFT GONADAL VEIN. UNSUCCESSFUL CATHETERIZATION OF THE RIGHT GONADAL VEIN."
SUSPECT MEDICAL DEVICE: UNSPECIFIED COOK NESTER EMBOLIZATION COIL OR MICROCOIL. OCCUPATION: PATIENT. INITIAL REPORTER ALSO SENT REPORT TO FDA: UNKNOWN. PMA/510(K) #: K153778. (B)(4). ADDITIONAL PROCEDURE REQUIRED TO REMOVE DEVICE. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS REPORTED A MALE PATIENT REQUIRED COOK NESTER COILS FOR A VARICOCELE EMBOLIZATION PROCEDURE ON OR ABOUT (B)(6) 2018. AS REPORTED, "DURING THE PROCEDURE, THE NESTER COILS WERE IMPLANTED. SOMETIME AFTER THE PROCEDURE, (PATIENT) BEGAN EXPERIENCING A LITANY OF HEALTH ISSUES, INCLUDING BLOOD CLOTS, CONTINUOUS ABDOMINAL CRAMPS, EXCRUCIATING ABDOMINAL PAIN, ANXIETY, CHRONIC BOWEL AND DIGESTIVE ISSUE, AND METAL ALLERGIC REACTIONS, WHICH BECAME EXACERBATED OVER TIME." PATIENT CONSULTED WITH A DIFFERENT PHYSICIAN WHO SUGGESTED A REVISION SURGERY TO REMOVE THE COILS. ON OR ABOUT (B)(6) 2019, THE PATIENT HAD A LAPAROSCOPIC EMBOLIZATION COIL REMOVAL PROCEDURE. AFTER THE COILS WERE REMOVED, THE PATIENT "BEGAN TO FEEL RELIEF. " NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 615463 | NESTER PLATINUM EMBOLIZATION COIL | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | COOK INC | N/A | 8567662 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Other| R | BOSTON SCIENTIFIC 4F SEL. HK1| BOSTON SCIENTIFIC 4F SEL. SIM2| BOSTON SCIENTIFIC 5F SEL. BERN| BOSTON SCIENTIFIC 5F SEL. C2| BOSTON SCIENTIFIC AMPLATZ SUPER STIFF .035INX75CM| COOK MPIS-402-NT-U-SST| MERIT MEDICAL 4F SIM2 IMPRESS| ST. JUDE HYDROSTEER GUIDEWIRE |