MITRACLIP
Report
- Report Number
- 2135147-2024-03446
- Event Type
- Death
- Date Received
- July 16, 2024
- Date of Event
- June 25, 2024
- Report Date
- October 8, 2024
- Manufacturer
- ABBOTT MEDICAL
- Product Code
- NKM
- UDI-DI
- 08717648288647
- PMA / PMN Number
- P100009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SN
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. IMAGING REVIEW: FOUR (4) FLUOROSCOPIC VIDEOS OF THE REPORTED DEVICE WERE PROVIDED. IT WAS REPORTED THAT DURING REMOVAL THE CLIP BECAME CAUGHT ON THE SGC SOFT TIP. TROUBLESHOOTING WAS PERFORMED AND "AS THE CLIP WAS REMOVED FROM THE GUIDE, IT OPENED TO APPROXIMATELY 60 DEGREES AND DETACHED FROM THE CDS." ALL FOUR VIDEOS PRESENT SIMILARLY IN WHICH THE CDS IS RETRACTED SO THAT THE DELIVERY CATHETER (DC) RADIOPAQUE TIP IS LOCATED WITHIN THE SGC TIP RING, WITH THE L-LOCK SHAFT EXITING THE SOFT TIP. THE CLIP MOVES INDEPENDENTLY OF THE DC AND "TILTS" OFF-AXIS (AT VARYING DEGREES) RELATIVE TO THE L-LOCK SHAFT; REFERENCE FIGURE 1 DEMONSTRATING THIS BEHAVIOR WITH PERTINENT COMPONENTS LABELED. IN THE VIDEOS, THE CLIP MAINTAINS A CONSISTENT CLIP ARM ANGLE OF ~30 DEGREES AND THE HINGE PINS ARE CORRECTLY ENGAGED WITH THE CONNECTOR WHICH CONFIRMS THE CLIP ASSEMBLY IS INTACT. IN ADDITION, THE CLIP MAINTAINS PROXIMITY TO THE L-LOCK SHAFT CONFIRMING THAT THE CLIP IS CONNECTED TO THE CDS VIA THE L-LOCK LINE, PREVENTING THE CLIP FROM FREELY FLOATING WITHIN THE LEFT ATRIUM. BASED ON THE REPORTED INFORMATION, THE VIDEOS WERE TAKEN AFTER THE CLIP BECAME CAUGHT ON THE SOFT TIP AND SUBSEQUENT TROUBLESHOOTING TO FREE THE CLIP; THE CINE PROVIDED DOES NOT SHOW THE CLIP ACTIVELY CAUGHT ON THE SOFT TIP. IN THE VIDEO TAKEN AT 18:50:09, AT THE 00:06 MARK, THE DISTAL L-LOCK TINES ARE VISIBLE AND THERE IS A CLEAR SEPARATION BETWEEN THE CLIP AND L-LOCK SHAFT (REFERENCE FIGURE 2). DURING NORMAL USE, PRIOR TO DEPLOYMENT, THE COUPLER IS LOCATED IN BETWEEN THE L-LOCK TINES WHICH PROVIDES AN OUTWARD FORCE, PUSHING THE TINES INTO THE CONNECTOR WINDOWS OF THE CLIP; THIS CREATES A MECHANICAL ATTACHMENT AND COAXIAL ALIGNMENT BETWEEN THE CLIP AND THE L-LOCK SHAFT. THEREFORE, THE REPORTED PREMATURE ACTIVATION (MECHANICAL SEPARATION) CAN BE CONFIRMED. THE COUPLER DOES NOT APPEAR TO BE VISIBLE IN BETWEEN THE L-LOCK TINES, INDICATING THAT A BREAK BETWEEN THE COUPLER TO THREADED STUD (OF THE CLIP) HAS OCCURRED. IF THIS CONNECTION IS BROKEN, THE COUPLER CAN RETRACT INTO THE DC SHAFT AND WITHDRAW FROM IN BETWEEN THE L-LOCK TINES. THIS ALLOWS THE L-LOCK TINES TO REST INWARDS TO THEIR NATURAL STATE AND DISCONNECT FROM THE CONNECTOR WINDOWS, INDUCING MECHANICAL SEPARATION AS OBSERVED IN THE VIDEOS PROVIDED. IT IS LIKELY THAT THE CLIP BECOMING CAUGHT ON THE SOFT TIP AND / OR SUBSEQUENT TROUBLESHOOTING MANEUVERS TO FREE THE CLIP EXERTED EXCESSIVE FORCE ON THE COUPLER TO THREADED STUD JUNCTION CONTRIBUTING TO THE INFERRED BREAK AND RESULTING IN THE PREMATURE DETACHMENT (MECHANICAL SEPARATION) OF THE CLIP FROM THE L-LOCK SHAFT, AS OBSERVED IN THE VIDEOS PROVIDED. PER THE INSTRUCTIONS FOR USE (EL2127667) SECTION 30.2 MITRACLIP SYSTEM REMOVAL WITH CLIP ATTACHED, STEP 30.2.1.2 PROVIDES THE FOLLOWING INSTRUCTIONS: "FULLY CLOSE THE CLIP ARMS AND CONTINUE TO TURN THE ARM POSITIONER UNTIL IT IS NO LONGER POSSIBLE TO TURN THE ARM POSITIONER. RETURN THE ARM POSITIONER TO NEUTRAL." IT IS IMPORTANT TO ENSURE THE ARM POSITIONER IS RETURNED TO NEUTRAL (AFTER FULLY CLOSING THE CLIP) PRIOR TO RETRACTION INTO THE SGC. WHEN THE ARM POSITIONER IN THE CLOSED POSITION THERE IS ACTIVE TENSION ON THE INTERNAL ACTUATOR ASSEMBLY, INCLUDING THE DISTAL COUPLER. IF THERE IS ACTIVE TENSION ON THE INTERNAL ACTUATOR ASSEMBLY DURING RETRACTION AND THE CLIP BECOMES CAUGHT ON THE SOFT TIP, THE COMPOUNDING TENSILE FORCES CAN RESULT IN A BROKEN COUPLER / BREAK IN THE COUPLER TO THREADED STUD JUNCTION. IT IS RECOMMENDED TO SEND ADDITIONAL FOLLOW UP TO THE ACCOUNT CONFIRMING THAT THE ARM POSITIONER WAS RETURNED TO THE NEUTRAL POSITION PRIOR TO ATTEMPTING TO RETRACT THE CDS INTO THE SGC. THERE ARE NO OTHER OBSERVATIONS BASED ON THE FLUORO VIDEOS PROVIDED.
ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED PREMATURE ACTIVATION AND DIFFICULT TO REMOVE (CDS/SGC) COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. ADDITIONALLY, THE THREADED STUD WAS OBSERVED TO BE BROKEN AND SCRATCHED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION AND THE RETURNED DEVICE ANALYSIS, THE CAUSE OF THE REPORTED DIFFICULT TO REMOVE (CDS/SGC) WAS UNABLE TO BE DETERMINED. THE OBSERVED BROKEN AND SCRATCHED THREADED STUD APPEARS TO BE RELATED TO TROUBLESHOOTING THE REPORTED DIFFICULT TO REMOVE (CDS/SGC). THE REPORTED PREMATURE ACTIVATION WAS A CASCADING EVENT OF THE OBSERVED BROKEN THREADED STUD. THE CAUSE OF THE REPORTED HYPOTENSION WAS UNABLE TO BE DETERMINED. THE REPORTED PATIENT DEATH WAS DUE TO PATIENT CONDITION. THE REPORTED PATIENT EFFECTS OF HYPOTENSION AND DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION, SURGICAL INTERVENTION, AND UNEXPECTED MEDICAL INTERVENTION WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. H6. HEALTH EFFECT - CLINICAL CODE REMOVED: 4438 EMBOLISM/EMBOLUS.
ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED PREMATURE ACTIVATION AND DIFFICULT TO REMOVE (CDS/SGC) COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. ADDITIONALLY, THE THREADED STUD WAS OBSERVED TO BE BROKEN AND SCRATCHED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION AND THE RETURNED DEVICE ANALYSIS, THE CAUSE OF THE REPORTED DIFFICULT TO REMOVE (CDS/SGC) WAS UNABLE TO BE DETERMINED. THE OBSERVED BROKEN AND SCRATCHED THREADED STUD APPEARS TO BE RELATED TO TROUBLESHOOTING THE REPORTED DIFFICULT TO REMOVE (CDS/SGC). THE REPORTED PREMATURE ACTIVATION WAS A CASCADING EVENT OF THE OBSERVED BROKEN THREADED STUD. THE CAUSE OF THE REPORTED HYPOTENSION WAS UNABLE TO BE DETERMINED. THE REPORTED EMBOLISM IS A CASCADING EVENT OF THE REPORTED PREMATURE ACTIVATION. THE REPORTED PATIENT EFFECTS OF HYPOTENSION AND EMBOLISM, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION, SURGICAL INTERVENTION, UNEXPECTED MEDICAL INTERVENTION, AND REMOVAL OF FOREIGN BODY WERE RESULTS OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING.
IT WAS REPORTED A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT GRADE MITRAL REGURGITATION (MR). A CLIP WAS ADVANCED INTO THE ANATOMY ACCESSING THE LEFT ATRIUM AND THEN STEERED DOWN INTO THE MITRAL VALVE. THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DECREASED, SO IT WAS DECIDED TO REMOVE THE CLIP DELIVERY SYSTEM (CDS) TO MANAGE THE PATIENT. AS PHYSICIANS WERE REMOVING THE CLIP, IT BECAME CAUGHT ON THE SOFT TIP OF THE GUIDE. TROUBLESHOOTING WAS PERFORMED, HOWEVER, AS THE CLIP WAS REMOVED FROM THE GUIDE, IT OPENED TO APPROXIMATELY 60 DEGREES AND DETACHED FROM THE CDS WHILE IN THE LEFT ATRIUM. THE PATIENT WAS IMMEDIATELY REFERRED TO SURGERY FOR THE SYSTEM TO BE REMOVED.
IT WAS REPORTED A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2024, TO TREAT GRADE MITRAL REGURGITATION (MR). A XTW MITRACLIP LOT: 30925R2080 CLIP WAS ADVANCED INTO THE ANATOMY ACCESSING THE LEFT ATRIUM (LA) AND THEN STEERED DOWN INTO THE MITRAL VALVE. WHILE THE CLIP WAS IN THE LA, THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DECREASED SPONTANEOUSLY, AND THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). THE CAUSE OF THE HYPOTENSION WAS NOT KNOWN. IT WAS DECIDED TO REMOVE THE CLIP DELIVERY SYSTEM (CDS) TO MANAGE THE PATIENT. AS PHYSICIANS WERE REMOVING THE CLIP, IT BECAME CAUGHT ON THE SOFT TIP OF THE GUIDE. TROUBLESHOOTING WAS PERFORMED, HOWEVER, AS THE CLIP WAS REMOVED FROM THE GUIDE, IT OPENED TO APPROXIMATELY 60 DEGREES WHILE STILL ATTACHED TO THE END OF THE SGC WHILE IN THE LEFT ATRIUM. THE PATIENT WAS IMMEDIATELY REFERRED TO SURGERY, THE ENTIRE SYSTEM WAS REMOVED DURING SURGICAL CONVERSION. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2024. THE CAUSE OF DEATH WAS NOTED AS PNEUMONIA, ISCHEMIC HEART DISEASE, AND VALVULAR HEART DISEASE. IT WAS NOTED THAT THE MITRACLIP PROCEDURE WAS A CONTRIBUTING FACTOR AS IT WAS THE REASON FOR THE SURGICAL CONVERSION.
IT WAS REPORTED A MITRACLIP PROCEDURE WAS PERFORMED ON (B)(6) 2024, TO TREAT GRADE MITRAL REGURGITATION (MR). A XTW MITRACLIP LOT: 30925R2080 CLIP WAS ADVANCED INTO THE ANATOMY ACCESSING THE LEFT ATRIUM (LA) AND THEN STEERED DOWN INTO THE MITRAL VALVE. WHILE THE CLIP WAS IN THE LA, THE PATIENT'S BLOOD PRESSURE SIGNIFICANTLY DECREASED SPONTANEOUSLY, AND THE PATIENT REQUIRED CARDIOPULMONARY RESUSCITATION (CPR). THE CAUSE OF THE HYPOTENSION WAS NOT KNOWN. IT WAS DECIDED TO REMOVE THE CLIP DELIVERY SYSTEM (CDS) TO MANAGE THE PATIENT. AS PHYSICIANS WERE REMOVING THE CLIP, IT BECAME CAUGHT ON THE SOFT TIP OF THE GUIDE. TROUBLESHOOTING WAS PERFORMED, HOWEVER, AS THE CLIP WAS REMOVED FROM THE GUIDE, IT OPENED TO APPROXIMATELY 60 DEGREES WHILE STILL ATTACHED TO THE END OF THE SGC WHILE IN THE LEFT ATRIUM. THE PATIENT WAS IMMEDIATELY REFERRED TO SURGERY, THE ENTIRE SYSTEM WAS REMOVED DURING SURGICAL CONVERSION. THE PATIENT WAS PLACED ON EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO). IT WAS REPORTED THAT THE PATIENT PASSED AWAY ON (B)(6) 2024. THE CAUSE OF DEATH WAS NOTED AS PNEUMONIA, ISCHEMIC HEART DISEASE, AND VALVULAR HEART DISEASE. IT WAS NOTED THAT THE MITRACLIP PROCEDURE WAS A CONTRIBUTING FACTOR AS IT WAS THE REASON FOR THE SURGICAL CONVERSION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 715094 | MITRACLIP | MITRAL VALVE REPAIR DEVICES | NKM | ABBOTT MEDICAL | 30925R2080 | 08717648288647 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death| H| R |