MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

Report

Report Number: 2024168-2014-02548
Event Type: Malfunction
Date Received: April 24, 2014
Date of Event: April 1, 2014
Report Date: April 1, 2014
Manufacturer: AV-TEMECULA-CT
Product Code: NKM
PMA / PMN Number: P100009
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: HEALTH PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

(B)(4). DESCRIPTION OF EVENT CONTINUED: THE GRIPPERS WERE RAISED, AND THE CLIP WAS CLOSED. DURING REMOVAL, SOME DIFFICULTY WAS NOTED IN RETRIEVING THE CLIP INTO THE SGC, BUT THIS WAS DONE SUCCESSFULLY. THE CDS WAS REMOVED AND REPLACED. IT WAS CONFIRMED THAT THE SLEEVE WAS NOT DEFLECTED MORE THAN 90 DEGREES AT ANY POINT. THE REST OF THE PROCEDURE WENT WITHOUT INCIDENT. TWO CLIPS WERE IMPLANTED AND THE MR WAS REDUCED TO 1+. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER. THE MITRACLIP IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

Additional Manufacturer Narrative · 1

(B)(4). EVALUATION SUMMARY: THE INCIDENT INFORMATION PROVIDED TO ABBOTT VASCULAR, THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND THE ANALYSIS OF THE RETURNED INNER COMPONENT OF THE DEVICE WERE REVIEWED. THE CLIP DELIVERY SYSTEM (CDS) WAS RETURNED CONSISTENT WITH THE REPORTED USE OF THE DEVICE AND/OR POST PROCEDURE HANDLING. THE LOCK LEVER WAS RETURNED RETRACTED APPROXIMATELY 3MM PAST THE BLUE LINE. THE CLIP WAS OPEN APPROXIMATELY 120 DEGREES. AN ATTEMPT WAS MADE TO OPEN THE CLIP ON BENCH WITH NO CURVES APPLIED AND THE CLIP OPENED TO 120 DEGREES, BUT WOULD NOT OPEN ANY FURTHER. IN AN EFFORT TO SIMULATE A CLINICAL CONDITION, THE RETURNED CDS AND A STEERABLE GUIDE CATHETER (SGC) WERE INSERTED INTO A WATER BATH WITH A SIMULATED INFERIOR VENA CAVA. WITH THE DC SHAFT EXTENDED APPROXIMATELY 1 CM, A CURVE WAS APPLIED TO THE SGC IN THE + DIRECTION AND 90 DEGREES WERE APPLIED TO THE CDS STEERABLE SLEEVE IN THE M DIRECTION. ANOTHER ATTEMPT WAS MADE TO OPEN THE CLIP, BUT IT WOULD NOT OPEN PAST 120 DEGREES. TROUBLESHOOTING MANEUVERS WERE PERFORMED TWICE BY PULLING THE LOCK LEVER UP TO 10MM PAST THE BLUE LINE AND THE CLIP JUMPED OPEN TO 120 DEGREES AND WOULD NOT OPEN ANY FURTHER. THUS, THE REPORTED DIFFICULTY OPENING THE CLIP WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. IN AN EFFORT TO DETERMINE A CAUSE FOR DIFFICULTY OPENING THE CLIP, THE CDS WAS REMOVED FROM THE WATER BATH TO DEPLOY THE CLIP. DURING CDS REMOVAL, THERE WERE NO ISSUES NOTED RETRACTED THE CLIP INTO THE GUIDE; THE CLIP DID NOT GET CAUGHT ON THE SGC SOFT TIP. EXAMINATION OF THE INNER COMPONENTS NOTED THAT THE ACTUATOR COUPLER WAS BENT APPROXIMATELY 2.5MM FROM THE DISTAL END OF THE COUPLER. THE ACTUATOR MANDREL WAS ALSO BENT APPROXIMATELY 3.6CM FROM THE DISTAL END OF THE COUPLER. THE CLIP WAS THEN INSTALLED ON A PROXY SHORTY CATHETER CONTAINING A PROXY ACTUATOR COUPLER (THEREFORE STRAIGHT) TO SIMULATE ACTUATION OF THE CLIP; THE CLIP OPENED TO INVERT SMOOTHLY WITHOUT ISSUE. POTENTIAL CAUSES DIFFICULTY OPENING THE CLIP CAN INCLUDE, BUT ARE NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY), USER TECHNIQUE/PROCEDURAL CONDITIONS (UNINTENDED CURVES ON THE DEVICE DURING ADVANCEMENT) OR MANUFACTURING ANOMALIES. WITH RESPECT TO THE PATIENT CONDITIONS, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE DIFFICULTY OPENING THE CLIP MAY BE INFLUENCED BY PATIENT ANATOMICAL MORPHOLOGY AND PATIENT DISEASE STATE (SUCH AS TORTUOSITY OF THE VESSEL, RESULTING IN INCREASED TENSION ON THE DEVICE), UNINTENDED CURVES ON THE DEVICE DURING ADVANCEMENT OR EXCESSIVE CURVES APPLIED TO THE DEVICE BY THE USER. IN THIS CASE, SINCE THE CLIP ACTUATED AS EXPECTED PRIOR TO USE AND THE ANALYSIS CONFIRMED THAT THE CLIP WAS ABLE TO INVERT SMOOTHLY USING A PROXY CATHETER, THE REPORTED DIFFICULTY WAS LIKELY ATTRIBUTED TO THE BEND IN THE ACTUATOR COUPLER AND/OR MANDREL. BASED ON THE INFORMATION REVIEWED, IT IS POSSIBLE THAT THERE WERE UNIDENTIFIED PROCEDURAL INTERACTIONS (E.G. CURVES ON THE DEVICE, DUE TO THE PATIENT ANATOMY) WHICH CAUSED MORE TENSION ON THE DEVICE, SUCH THAT THE COUPLER AND MANDREL BECAME BENT AND THEREFORE CONTRIBUTED TO THE CLIP DIFFICULT TO OPEN; HOWEVER, THIS CANNOT BE CONFIRMED. ALTHOUGH THE REPORTED DIFFICULTY WAS LIKELY ATTRIBUTED TO THE NOTED BENDS IN THE ACTUATOR ASSEMBLY, A DEFINITIVE CAUSE FOR THIS DAMAGE COULD NOT BE DETERMINED BASED ON THE INFORMATION REVIEWED AND THE ANALYSIS OF THE RETURNED DEVICE. IT WAS FURTHER NOTED THAT DURING CDS REMOVAL, SOME DIFFICULTY WAS NOTED IN RETRIEVING THE CLIP INTO THE SGC, BUT IT WAS ULTIMATELY SUCCESSFUL. POTENTIAL CAUSES FOR DIFFICULTY RETRACTING THE CLIP INTO THE GUIDE TIP CAN INCLUDE, BUT ARE NOT LIMITED TO, PROCEDURAL CONDITIONS (CURVES ON THE GUIDE DURING CDS REMOVAL), USER TECHNIQUE, SUCH AS CLIP NOT BEING FULLY CLOSED AND THE ORIENTATION OF THE CLIP WITH RESPECT TO THE GUIDE TIP DURING REMOVAL, OR MANUFACTURING ANOMALIES. IN THIS CASE, IT IS LIKELY THAT THE INITIAL ORIENTATION OF THE CLIP UPON RETRACTION OF THE CDS CAUSED ONE OF THE CLIP ARMS TO INTERACT WITH THE GUIDE TIP, RESULTING IN THE DIFFICULTY REMOVING THE CDS. BASED ON THE INFORMATION REVIEWED, THE DIFFICULTY REMOVING THE DEVICE/CLIP CAUGHT ON THE GUIDE TIP APPEARS TO BE RELATED TO USER TECHNIQUE/PROCEDURAL CONDITIONS. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY OF THE REPORTED LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

Description of Event or Problem · 1

THIS REPORT IS BEING FILED TO CAPTURE THE DIFFICULTY EXPERIENCED DURING REMOVAL OF THE CLIP DELIVERY SYSTEM INTO THE STEERABLE GUIDE CATHETER WHICH HAS THE POTENTIAL TO CAUSE OR CONTRIBUTE TO PATIENT INJURY. IT WAS REPORTED THAT THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4, WITH A VERY MEDIAL JET. THE CLIP DELIVERY SYSTEM (CDS) PASSED ALL FUNCTIONAL TESTS DURING PREPARATION. THE ARM POSITIONER AND PLUS/MINUS KNOB WERE VERIFIED TO BE IN NEUTRAL. CARE WAS TAKEN TO NOT OVER-TIGHTEN THE ARM POSITIONER. THE CDS WAS INSERTED AND ADVANCED WITHOUT ISSUE. AFTER THE SLEEVE WAS CURVED TO ABOUT 80 DEGREES WITH THE M KNOB, ABOUT 120 DEGREES OF THE PLUS KNOB WAS APPLIED TO OPTIMIZE THE A-P TRAJECTORY. THE CDS WAS STEERED TO A PERPENDICULAR TRAJECTORY RELATIVE TO THE MITRAL VALVE, THE GRIPPERS WERE RAISED, AND THE CLIP WAS ATTEMPTED TO BE OPENED IN THE LEFT ATRIUM. THE LOCK LEVER WAS GENTLY PULLED TO EXPOSE THE BLUE LINE, THE ARM POSITIONER WAS TURNED ONE-HALF TURN CLOCKWISE AND THEN COUNTER-CLOCKWISE TO OPEN, BUT THE CLIP DID NOT OPEN. THE ARM POSITIONER WAS RETURNED TO NEUTRAL AND THE LOCK LEVER WAS RETRACTED FARTHER. THE ARM POSITIONER WAS TURNED FARTHER IN THE CLOSE DIRECTION BEFORE TURNING IN THE OPEN DIRECTION, BUT THE CLIP DID NOT OPEN. THESE STEPS WERE INCREMENTALLY ITERATED UNTIL THE ARM POSITIONER WAS BOTTOMED OUT IN THE CLOSE DIRECTION. ON THAT ITERATION, THE CLIP OPENED TO ABOUT A GRASPING ANGLE, BUT WOULD NOT OPEN FURTHER. THE GRIPPER LEVER WAS ADVANCED, AND THIS LAST ITERATION WAS REPEATED, BUT THE CLIP DID NOT OPEN PAST A GRASPING ANGLE. IT WAS DECIDED TO REPLACE THE CDS.

Description of Event or Problem · 1

SUBSEQUENT TO THE INITIAL REPORT, THE FOLLOWING INFORMATION WAS REPORTED: THERE WERE NO TURNS ON THE DELIVERY CATHETER HANDLE AT ANY POINT DURING THE PROCEDURE. THE GUIDE WAS STRAIGHTENED DURING CLIP DELIVERY SYSTEM (CDS) REMOVAL, AND THE CLIP WAS CONFIRMED TO BE FULLY CLOSED DURING REMOVAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
249204	MITRACLIP SYSTEM CLIP DELIVERY SYSTEM	MITRACLIP DELIVERY SYSTEM	NKM	AV-TEMECULA-CT		10304625

Patients

Seq	Age	Sex	Outcome	Treatment
1	90 YR