EXCOR®
Report
- Report Number
- 3004582654-2024-00035
- Event Type
- Malfunction
- Date Received
- August 1, 2024
- Date of Event
- July 5, 2024
- Report Date
- May 13, 2025
- Manufacturer
- BERLIN HEART GMBH
- Product Code
- DSQ
- PMA / PMN Number
- P160035
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
ON 2024-08-01, THE EXCOR CANNULA LOT NO. 00140792 WAS RETURNED TO BERLIN HEART GMBH FOR INVESTIGATION. THE DAMAGED PART OF THE CANNULA WAS FIRST EXAMINED BY BHI WHERE IT WAS VISUALLY CONFIRMED THAT THE LUMEN WAS OCCLUDED BY THE INNER COATING OF THE CANNULA. FURTHER ANALYSIS WAS PERFORMED AT BERLIN HEART GMBH ACCORDING TO BHRL-PE-004 "COMPLAINT ANALYSIS OF EXCOR CANNULAS, CONNECTOR SETS, AND CANNULA EXTENSION SETS" DURING THE INITIAL VISUAL INSPECTION OF THE RETURNED CANNULA SECTION, A PEELED INNER SILICONE COATING WAS VISUALLY CONFIRMED. HOWEVER, THE OCCLUSION OF THE LUMEN BY THE PEELED INNER COATING COULD NOT BE VERIFIED. BECAUSE OF THE ELASTICITY OF THE INNER SILICONE COATING, BERLIN HEART GMBH CONCLUDED THAT THE SILICONE HAD RETURNED TO ITS ORIGINAL SHAPE WITHOUT PERMANENT DEFORMATION DURING TRANSPORTATION FROM BHI TO BH GMBH. CT SCANS WERE PERFORMED IN AN EXTERNAL, INDEPENDENT LABORATORY. THE EVALUATION OF THE CT SCAN ALSO CONFIRMED PEELING OF THE INNER SILICONE COATING BUT NO OCCLUSION OF THE LUMEN IN THE RETURNED CANNULA. AN ADDITIONAL TEST WAS PERFORMED WITH THE CARDIOPULMONARY BYPASS (CPB) CONNECTOR PROVIDED BY THE SITE. THE CPB CONNECTORS WERE PUSHED INTO A SIMILARLY COATED CANNULA TO PROVOKE THE POSSIBILITY OF PEELING OF THE INNER COATING OF THE CANNULA. FOR THIS, THE CANNULA TUBE WAS SHORTENED WITH SCISSORS AND THEN THE CPB CONNECTOR WAS PUSHED INTO THE CANNULA TUBE. FOLLOWING ONE TRIAL, IT BECAME POSSIBLE TO PEEL OFF THE INNER SILICONE COATING OF THE CANNULA TUBE. IT IS POSSIBLE THAT THE INNER COATING COULD BE DAMAGED OR SCRAPED OFF WHEN INSERTING THE CANNULA ONTO AN UNAPPROVED CONNECTOR. THE EXACT CAUSE OF THE DELAMINATION REMAINS UNKNOWN BUT APPEARS TO OCCUR VERY RARELY AND SPORADICALLY. THE SCRAPING OF THE INNER SILICONE COATING HAS BEEN OBSERVED WHEN SITES USE CONNECTORS OTHER THAN THOSE PROVIDED BY BERLIN HEART. FAILURE INVESTIGATIONS PREVIOUSLY CONDUCTED DEMONSTRATED THAT, DESPITE APPLYING MECHANICAL FORCES, BERLIN HEART WAS UNABLE TO REPLICATE THE DELAMINATION OF THE INNER SILICONE COATING OBSERVED WITH ITS CONNECTORS (E-24-108: DELAMINATION OF INNER COATING IN CANNULA). ADDITIONAL TESTING PERFORMED BY THE MANUFACTURER CONFIRMED THAT CANNULA TEST SAMPLES FROM CURRENT PRODUCTION LOTS NOR THOSE FROM THE SUSPECTED CANNULA LOT EXHIBITED FURTHER DELAMINATION OF THE INNER SILICONE COATING WHEN SUBJECTED TO MECHANICAL FORCE. HOWEVER, BERLIN HEART WAS ABLE TO REPLICATE DELAMINATION OF THE INNER SILICONE COATING THROUGH TESTING PERFORMED WITH THE CPB CONNECTOR AND A CANNULA TEST SAMPLE. IN CONCLUSION, THE EXACT CAUSE OF THE DELAMINATION OF THE INNER COATING COULD NOT BE DETERMINED. HOWEVER, IT SEEMS THAT DELAMINATION OF THE INNER SILICONE COATING IS FAVORED BY THE USE OF CONNECTORS THAT ARE NOT MANUFACTURED OR DISTRIBUTED BY THE MANUFACTURER, BERLIN HEART. CHAPTER 6 OF THE IFU INCLUDES A WARNING THAT STATES, "COMPONENTS FROM DIFFERENT MANUFACTURERS OR VAD SYSTEMS SHOULD NOT BE USED TOGETHER WITH THE EXCOR SYSTEM."
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED IN RESPONSE TO THE FDA LETTER DATED 5/1/2025. THE INITIAL MDR REPORT 3004582654-2024-00035 HAS BEEN SUBMITTED ON 08/01/2024.
THE CANNULA (LOT NO. 00140792) IS IN USE ON THE PATIENT SINCE (B)(6) 2024 FOR 15 DAYS UNTIL THE TIME OF THE EVENT ON 2024-07-05. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR ARTERIAL CANNULA LOT NO. 00140792. THIS PRODUCT WAS PRODUCED ACCORDING TO OUR SPECIFICATION. IFU 1000721 CONTAINS A WARNING ADVISING USERS TO USE ONLY EXCOR COMPONENT WITH EXCOR SYSTEM AND TO AVOID COMBINING EXCOR COMPONENTS WITH OTHER SYSTEMS. THE EVENT IS REPORTED CONTAINING THE INFORMATION THAT IS CURRENTLY AVAILABLE. THE PRODUCT IN QUESTION IS RETURNED TO THE MANUFACTURER FOR INVESTIGATION. A FOLLOW-UP MDR WILL BE PROVIDED WITH THE MANUFACTURERS FINDINGS ONCE THE INVESTIGATION IS COMPLETED.
THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED IN RESPONSE TO THE FDA LETTER DATED 9/5/2024. THE INITIAL MDR REPORT (B)(4) HAS BEEN SUBMITTED ON 08/01/2024.
ON (B)(6) 2024 BERLIN HEART INC. CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC, THAT STRAIGHT CONNECTORS (NOT BERLIN HEART CONNECTORS) CONNECTED TO THE EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN Ø6 MM; L 25 CM APPEARED TO BE CRACKED. THE PATIENT WAS IMPLANTED WITH EXCOR CANNULA IN COMBINATION WITH STRAIGHT CONNECTORS (NOT BERLIN HEART CONNECTORS) AND ANOTHER VAD SYSTEM (NOT BERLIN HEART). THE CLINIC DECIDED TO CHANGE THE CANNULA CONNECTOR AREA. IT WAS NOTED THAT AS SOON AS THE CANNULA WAS DISCONNECTED FROM THE CONNECTOR, THE CANNULA HAD SOME SORT OF DELAMINATION AT THE END. THE CLINIC FOUND THAT THE ANOMALY OCCURRED IN THE CANNULA, NOT THE CONNECTOR. THE ANOMALY OF THE CANNULA SHOWED A PARTIAL DISRUPTION OF THE INNERMOST LINING (LUMEN) OF THE MOST DISTAL END OF THE AORTIC CANNULA, THE PORTION THAT HAD BEEN ADVANCED ONTO THE CONNECTOR. ACCORDING TO THE ATTENDING SURGEON, THERE WAS A NEARLY COMPLETE OCCLUSION OF THE LUMEN BY THE "DISSECTED" LINING, IN A WAY ANALOGOUS TO AN AORTIC DISSECTION. THE DAMAGED PORTION OF THE CANNULA WAS CUT OFF AND A NEW CONNECTOR WAS INSERTED ON EACH SIDE, TAKING CARE NOT TO DAMAGE THE CANNULAS. THE PATIENT REMAINED STABLE AND CONSCIOUS THROUGHOUT THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 885662 | EXCOR® | VENTRICULAR (ASSIST) BYPASS | DSQ | BERLIN HEART GMBH | C80G-021M | 00140792 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 10 MO | Female |