CONCERTO COIL

Report

Report Number: 2029214-2018-01041
Event Type: Malfunction
Date Received: December 10, 2018
Date of Event: November 13, 2018
Report Date: March 5, 2019
Manufacturer: MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR
Product Code: KRD
PMA / PMN Number: K090046
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: GM
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 0

UPDATED WITH CODE C133513. THE DEVICE WAS RETURNED WITH THE SHEATH, DELIVERY SYSTEM AND IMPLANT. THE RENEGADE 2.8F CATHETER WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, THE CATHETER APPEARED TO BE COMPATIBLE FOR USE WITH THE COIL AS IT APPEARS TO HAVE AN INNER DIAMETER (ID) OF 0.021¿ (VIA ONLINE). THERE IS SIGNIFICANT BLOOD INSIDE THE SHEATH AND THE IMPLANT AND PUSHER ARE STUCK INSIDE THE SHEATH DUE TO THE CAKED BLOOD. THE DISTAL END OF THE IMPLANT IS INTACT AND DOES NOT SUGGEST THAT THE COIL STRETCH OR SEPARATED DURING USE. THE DISTAL END OF THE IMPLANT IS 2CM FROM THE DISTAL END OF THE SHEATH. INSPECTION OF THE ATTACHMENT POINT BETWEEN THE IMPLANT AND PUSHER WITHIN THE SHEATH SHOW THAT THEY ARE STILL CONNECTED AND HAVE NOT DETACHED, THIS IS 54.2CM FROM THE DISTAL END OF THE SHEATH. THE SKIVE PORTION OF THE AXIUM PUSHER IS SEVERELY KINKED WITHIN THE SHEATH. THERE IS NO EVIDENCE OF DAMAGE OR BUCKLING OF THE COIL ANYWHERE ALONG ITS L ENGTH INSIDE THE SHEATH. PUSHING OR PULLING ON THE IMPLANT TO REMOVE IT FROM THE SHEATH IS IMPOSSIBLE GIVEN THE LONG LENGTH OF THE COIL AND PRESENCE OF BLOOD. THE WAVELOCK IS PRESENT ON THE SHEATH AND PROXIMAL TO THE LOCATION WHERE THE PUSHER HAS BUCKLED. THE VIS MEASUREMENT OF THE ID OF THE SHEATH MEASURED TO BE WITHIN SPECIFICATION. NO OTHER ANOMALIES WERE OBSERVED. BASED ON THE ANALYSIS FINDINGS, THE CUSTOMER REPORTS OF "COIL STUCK MICROCATHETER" AND "COIL SEPARATION¿ WERE NOT CONFIRMED. EVIDENCE SUGGESTS THAT THE COIL WAS STUCK IN THE SHEATH, NOT THE RENEGADE 2.8F CATHETER. THE SHIELD COIL IS PRESENT AND INTACT ON THE PUSHER TIP. THE ACTUATOR INTERFACE AND THE TWR CRIMPS ARE INTACT AND THERE HAS BEEN NO ATTEMPT TO DETACH THE COIL. THERE WERE NO OUT OF SPECIFICATION CONDITIONS THAT CONTRIBUTED TO THE EVENT AS ALL MEASURABLE COMPONENTS WERE FOUND TO BE WITHIN SPECIFICATION. THE DEGREE OF BLOOD IN THE SHEATH IS INDICATIVE OF A LACK OF CONTINUOUS FLUSH THROUGH THE MICROCATHETER AND SHEATH AND LIKELY CONTRIBUTED TO THE FRICTION EXPERIENCED BY THE PHYSICIAN. THE DAMAGE TO THE PUSHER WAS LIKELY THE RESULT OF AN ATTEMPT BY THE PHYSICIAN TO FREE THE STUCK COIL. THERE WAS NO INDICATION THAT THE EVENT WAS RELATED TO A POTENTIAL MANUFACTURING ISSUE AND NO DHR WAS REQUESTED; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED. PER INSTRUCTIONS FOR USE (IFU), "SLOWLY ADVANCE THE COIL OUT OF THE INTRODUCER SHEATH INTO THE PALM OF YOUR GLOVED HAND AND INSPECT FOR IRREGULARITIES OF THE COIL OR THE DETACHMENT ZONE. DUE TO POTENTIAL RISKS OF IRREGULARITIES, A VISUAL PROOF SHOULD BE PERFORMED. IF IRREGULARITIES EXIST, REPLACE WITH A NEW COIL. GENTLY IMMERSE THE COIL AND ITS DETACHMENT ZONE IN HEPARINIZED SALINE. TAKE CARE NOT TO STRETCH THE COIL DURING THIS PROCEDURE, IN ORDER TO PRESERVE THE COIL MEMORY. WHILE STILL IMMERSED IN THE HEPARINIZED SALINE, POINT INTRODUCER SHEATH VERTICALLY INTO SALINE AND GENTLY RETRACT THE DISTAL TIP OF THE COIL INTO THE INTRODUCER SHEATH. HANDLE THE COIL WITH CARE TO AVOID DAMAGE BEFORE OR DURING TREATMENT.¿ BASED ON THE ANALYSIS FINDINGS, THIS EVENT IS NO LONGER REPORTABLE. MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Additional Manufacturer Narrative · 1

THE DEVICE INVOLVED IN THE EVENT HAVE NOT BEEN RETURNED FOR EVALUATION. CORRESPONDENCE HAS BEEN SENT FOR THE DEVICE AND ADDITIONAL INFORMATION. ONCE THE DEVICE OR NEW INFORMATION HAS BEEN RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

Description of Event or Problem · 1

MEDTRONIC RECEIVED REPORT THAT DURING A COILING EMBOLIZATION TREATMENT, THE MEDTRONIC IMPLANT COIL DETACHED WHILE BEING ADVANCED WITHIN THE MIDDLE SEGMENT OF THE RENEGADE 28 CATHETER. THERE WAS NO PATIENT INJURY. THE CATHETER WAS DISCARDED AT THE SITE. NO PATIENT INJURY OCCURRED. THE DEVICES WERE PREPARED AND USED PER THE INSTRUCTIONS FOR USE (IFU).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
986818	CONCERTO COIL	DEVICE, EMBOLIZATION, VASCULAR	KRD	MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR	PV-20-50-HELIX	A606803

Patients

Seq	Age	Sex	Outcome	Treatment
1