KRD DEVICE, EMBOLIZATION, VASCULAR
Report
- Report Number
- 1820334-2019-02969
- Event Type
- Injury
- Date Received
- November 27, 2019
- Report Date
- April 7, 2020
- Manufacturer
- COOK INC
- Product Code
- KRD
- 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. INVESTIGATION ¿ EVALUATION: DURING A ROUTINE SEARCH OF THE FDA DOCKET FOR THE IMMUNOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE, COOK FOUND A COMMENT POSTED REGARDING NESTER EMBOLIZATION COILS. THE PATIENT STATED THEY RECEIVED THE EMBOLIZATION COILS FOR AN UNKNOWN PROCEDURE IN 2008. IT WAS REPORTED THAT AT AN UNKNOWN TIME PERIOD AFTER THE COILS WERE PLACED, THEY MIGRATED TO AN UNKNOWN LOCATION. IT WAS REPORTED THAT THE MIGRATION CAUSED THE PATIENT TO REQUIRE A FULL HYSTERECTOMY IN 2017. THE REPORTER STATES SHE HAS SUFFERED TOTAL DISABILITY, UNKNOWN IMMUNE DISORDER, AND STILL IS SUFFERING FROM CHRONIC PAIN. THE REPORTER STATES THAT THERE IS STILL "A PIECE THAT NO [DOCTOR] DARES TO REMOVE." NO ADDITIONAL INFORMATION WAS PROVIDED IN THE FORUM REGARDING THE DEVICES USED OR THE PATIENT'S OUTCOME. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. APPROPRIATE INSPECTIONS ARE IN PLACE RELATED TO THIS FAILURE. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER FOR THE COMPLAINT DEVICE. BECAUSE THE IMPLANT FACILITY IS UNKNOWN, COOK IS UNABLE TO IDENTIFY THE COMPLAINT LOT. THEREFORE, COOK IS UNABLE TO REVIEW THE DEVICE HISTORY RECORD FOR THIS COMPLAINT. PRODUCT LABELING WAS ALSO REVIEWED AS A PART OF THE INVESTIGATION. INSTRUCTIONS FOR USE ARE PACKAGED WITH THIS DEVICE. RELEVANT SECTIONS INCLUDE: "WARNINGS: POSITIONING OF EMBOLIZATION COILS AND MICROCOILS 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 OBSTRUCTING A NORMAL AND ESSENTIAL ARTERIAL CHANNEL. COIL DELIVERY TECHNIQUE AND COIL SIZE SELECTION: LONG-TERM OCCLUSION DEPENDS ON ACHIEVING CROSS-SECTIONAL OCCLUSION OF THE BLOOD VESSEL, AND COAXIAL CATHETERS PROVIDE THE ABILITY TO CONTROL PLACEMENT OF COILS AND PERMANENT OCCLUSION. THE COMBINATION OF THE COAXIAL TECHNIQUE AND EITHER THE ANCHOR OR SCAFFOLD TECHNIQUE SIGNIFICANTLY ENHANCES STABILITY OF COIL DEPLOYMENT. IN GENERAL, THE FIRST COIL SELECTED SHOULD HAVE A DIAMETER THAT IS 20% LARGER, OR A T LEAST 2MM OVERSIZED, THAN THE VESSEL THAT IS BEING OCCLUDED." THE IFUS ALSO INSTRUCT TO PERFORM A FINAL ANGIOGRAM TO CONFIRM COIL POSITION WITHIN TARGET VESSEL. IT WAS CONCLUDED THERE IS NO EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING MATERIAL IN HOUSE OR IN THE FIELD. THE COIL SIZE, TARGET LOCATION, AND VESSEL SIZE ARE UNKNOWN. BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT, AND RESULTS OF THE INVESTIGATION, IT WAS CONCLUDED THAT COMPONENT FAILURE WITHOUT IDENTIFIED DESIGN OR MANUFACTURING DEFICIENCY CONTRIBUTED TO THIS EVENT. 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.
NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.
SUSPECT MEDICAL DEVICE: "INTERLOCKING COILS FROM NESTER". IMPLANT DATE: DEVICE IMPLANTED 2008 . OCCUPATION: UNKNOWN. REPORT SOURCE: OTHER: FOOD AND DRUG ADMINISTRATION (FDA) NOTICE: IMMUNOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE . (URL: HTTPS://WWW.REGULATIONS.GOV/DOCUMENT?D=FDA-2019-N-3767-0019) . PMA/510(K) #: UNKNOWN. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.
IT WAS DISCOVERED DURING A ROUTINE SEARCH OF THE FDA DOCKET FOR THE IMMUNOLOGY DEVICES PANEL OF THE MEDICAL DEVICES ADVISORY COMMITTEE, THAT A FEMALE PATIENT POSTED A PUBLIC COMMENT STATING THE PATIENT RECEIVED "NESTER INTERLOCKING COILS," FOR AN UNKNOWN PROCEDURE IN 2008. THE EXACT PRODUCT IDENTIFIERS WERE NOT REPORTED. IT WAS REPORTED THAT IN AN UNKNOWN TIME PERIOD AFTER THE COILS WERE PLACED, THEY MIGRATED TO AN UNKNOWN LOCATION. IT WAS REPORTED THAT THE MIGRATION CAUSED THE PATIENT TO REQUIRE A FULL HYSTERECTOMY IN 2017. THE REPORTER STATES SHE HAS SUFFERED TOTAL DISABILITY, UNKNOWN IMMUNE DISORDER, AND STILL IS SUFFERING FROM CHRONIC PAIN (LOCATION OF PAIN IS UNKNOWN). THE REPORTER STATES THAT THERE IS STILL "A PIECE THAT NO ONE DARES TO REMOVE." NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1176490 | KRD DEVICE, EMBOLIZATION, VASCULAR | KRD | COOK INC | N/A | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention| S |