MITRACLIP SYSTEM CLIP DELIVERY SYSTEM
Report
- Report Number
- 2024168-2014-03513
- Event Type
- Injury
- Date Received
- June 2, 2014
- Date of Event
- May 1, 2014
- Report Date
- May 8, 2014
- Manufacturer
- AV-TEMECULA-CT
- Product Code
- NKM
- PMA / PMN Number
- P100009
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). ESTIMATED DATE (REPORTED AS APPROXIMATELY 5 WEEKS POST PROCEDURE). THE MITRACLIP REMAINS IMPLANTED ON THE MITRAL VALVE LEAFLET. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.
(B)(4).
(B)(4). THE MITRACLIP WAS NOT RETURNED AS IT REMAINED ATTACHED TO THE MITRAL VALVE LEAFLET. THE ANALYSIS OF THIS COMPLAINT WILL BE AN ASSESSMENT OF THE MANUFACTURING RECORDS/COMPLAINT HISTORY AND INFORMATION PROVIDED BY THE REPORTER TO ABBOTT VASCULAR. POTENTIAL CAUSES FOR SINGLE LEAFLET DEVICE ATTACHMENT (SLDA) LEADING TO INCOMPLETE COAPTATION ARE, BUT NOT LIMITED TO, PATIENT CONDITIONS (SUCH AS ANATOMICAL MORPHOLOGY/PATHOLOGY, ASSOCIATED COMORBIDITIES, AND DISEASE STATE), USER TECHNIQUE/PROCEDURAL CONDITIONS (PROCEDURAL CIRCUMSTANCES INFLUENCING THE ABILITY TO GRASP THE LEAFLETS) OR MANUFACTURING ANOMALIES. AS PART OF THE MITRACLIP MANUFACTURING PROCESS, ALL DEVICES ARE SUBJECT TO VISUAL AND FUNCTIONAL INSPECTION TO VERIFY PRODUCT QUALITY. REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THIS DEVICE PASSED ALL IN-PROCESS AND FINAL INSPECTIONS, INCLUDING VERIFICATION THAT THE CLIP AND ITS COMPONENTS WERE FUNCTIONING AS EXPECTED. THERE WERE NO NON-CONFORMANCES ISSUED FOR THIS LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY OF THE ELECTRONIC COMPLAINT HANDLING DATABASE INDICATES THERE HAVE BEEN NO OTHER REPORTED INCIDENTS FROM THIS LOT. THERE WERE NO REPORTED DEVICE ISSUES WHILE FUNCTIONALLY INSPECTING THE CDS DURING DEVICE PREPARATION, WHICH IS AN INDICATION THAT THE DEVICE WAS FUNCTIONING PROPERLY PRIOR TO USE. WITH RESPECT TO THE PATIENT CONDITION, PROCEDURAL CONDITIONS AND/OR USER TECHNIQUE, THE SLDA MAY BE INFLUENCED BY THE DIFFICULTIES WITH VISUALIZATION OR MORPHOLOGY OF THE MITRAL VALVE, INCLUDING TETHERING OF THE LEAFLETS, CHORDAE INTERACTION, OR LEAFLETS THAT ARE THINNER/THICKER, RESTRICTED AND PROLAPSED. INFORMATION RECEIVED INDICATED THAT THE PATIENT HAD A PRE-EXISTING MODERATE PROLAPSE OF THE POSTERIOR LEAFLET WHICH WAS JUDGED TECHNICALLY FEASIBLE AND COMPATIBLE WITH THE MITRACLIP IMPLANTATION. HOWEVER, IN THIS CASE, IT IS POSSIBLE THAT THE PATIENT ANATOMY MAY HAVE CONTRIBUTED TO THE SLDA OF THE CLIP; BUT, THIS CANNOT BE DEFINITIVELY CONFIRMED. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED SLDA CANNOT BE DETERMINED. THERE DOES NOT APPEAR TO BE ANY EVIDENCE OF A QUALITY DEFICIENCY ASSOCIATED WITH THIS DEVICE. THE REPORTED PATIENT EFFECT OF MITRAL REGURGITATION IS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE AS KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.
SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED: THE TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) DONE ON (B)(6) 2014 DID NOT CLEARLY SHOW THE SINGLE LEAFLET DEVICE ATTACHMENT BUT SHOWED THE MITRAL REGURGITATION (MR) GRADE 4+. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) DONE ON (B)(6) 2014 CONFIRMED THAT THE MITRACLIP WAS ONLY ATTACHED TO THE ANTERIOR LEAFLET AND WAS NOT ATTACHED TO THE POSTERIOR LEAFLET; MR GRADE WAS 4+. THE PATIENT WAS REHOSPITALIZED ON (B)(6) 2014 AND UNDERWENT SURGICAL MITRAL VALVE REPLACEMENT ON (B)(6) 2014. THE PATIENT IS IN STABLE CONDITION AND IS FOLLOWING A REHABILITATION PROGRAM. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
THIS REPORT IS FILED AS IT WAS SUSPECTED THAT THE IMPLANTED CLIP DETACHED FROM ONE LEAFLET AND MITRAL REGURGITATION WORSENED. IT WAS REPORTED THAT ON (B)(6) 2014, A MITRACLIP PROCEDURE WAS PERFORMED. DURING THE PROCEDURE, TWO GRASPING ATTEMPTS WERE NEEDED. THE FIRST ATTEMPT WAS PERFORMED IN THE CENTRAL PORTION OF A2/P2 WITHOUT SATISFACTORY EFFECT ON THE MITRAL REGURGITATION (MR). THE SECOND ATTEMPT WAS PERFORMED IN CENTRO-MEDIAL PORTION OF A2/P2 WAS CONSIDERED EFFECTIVE FOR MR REDUCTION. THE ANATOMY WAS NOT CHALLENGING AND THERE WAS NO DIFFICULTY CONFIRMING LEAFLET INSERTION. ONE CLIP WAS IMPLANTED REDUCING THE MIXED MITRAL REGURGITATION GRADE FROM 4 TO 2. APPROXIMATELY 5 WEEKS POST PROCEDURE, THE MITRAL REGURGITATION WORSENED (DEFINED AS MODERATE) AND THE TRANSTHORACIC ECHOCARDIOGRAM (TTE) SHOWED THAT THE CLIP WAS MORE MOBILE THAN USUAL. THE PHYSICIAN SUSPECTS THAT THE CLIP MAY HAVE DETACHED FROM ONE LEAFLET. THE TTE DOES NOT CLEARLY SHOW THIS AND THE DETACHMENT COULD NOT BE ABSOLUTELY CONFIRMED. THE PATIENT WAS FEELING SLIGHTLY BETTER THAN BEFORE THE MITRACLIP PROCEDURE. NO ADDITIONAL TREATMENT IS PLANNED. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
SUBSEQUENT TO THE INITIAL MEDWATCH REPORT, ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE PATIENT HAD A PREEXISTING MODERATE PROLAPSE OF THE POSTERIOR LEAFLET. BEFORE THE MITRACLIP PROCEDURE, THE PATIENT WAS SCREENED WITH THE TRANSESOPHAGEAL ECHOCARDIOGRAM IMAGING. BOTH LEAFLETS, INCLUDING THE PROLAPSE OF THE POSTERIOR LEAFLET, WERE JUDGED TECHNICALLY FEASIBLE AND COMPATIBLE WITH A MITRACLIP IMPLANTATION. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 321995 | MITRACLIP SYSTEM CLIP DELIVERY SYSTEM | MITRACLIP DELIVERY SYSTEM | NKM | AV-TEMECULA-CT | 10286135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| O| R |