CERTAS INLIN VLV ONLY W/SPHNGD
Report
- Report Number
- 3013886523-2022-00378
- Event Type
- Death
- Date Received
- August 17, 2022
- Date of Event
- June 16, 2022
- Report Date
- February 23, 2023
- Manufacturer
- INTEGRA LIFESCIENCES SWITZERLAND SAR
- Product Code
- JXG
- PMA / PMN Number
- K143111
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
ADDITIONAL INFORMATION RECEIVED: THE INTEGRA ACCOUNT MANAGER MET WITH THE SURGEON IN PERSON AND DISCUSSED THE CASE DETAILS: THE PATIENTS PROGNOSIS WAS CHALLENGING FROM THE INITIAL PRESENTATION WHEN THEY PRESENTED WITH AN INTRAVENTRICULAR BLEED. THE SURGEON DOES NOT ATTRIBUTE THE PATIENTS DEATH TO THE VALVE. THE BELOW INFORMATION INCLUDES THAT THE PATIENT HAD A FALL WHILE IN THE BRAIN INJURY UNIT. THE INTEGRA ACCOUNT MANAGER MENTIONED THERE IS A QUERY AS TO WHETHER THE PATIENT HIT THE VALVE AT THE SIPHNGUARD POINT WHEN THEY FELL AND WHETHER DUE TO EXCESSIVE SCARRED TISSUE IN THE PATIENTS ANATOMY THE VALVE WAS HYPERFLEXED IN SITU. PATIENT¿S UNDERLYING MEDICAL CONDITION THAT WARRANTED THE SHUNT - HYDROCEPHALUS. OTHER RELEVANT MEDICAL HISTORY - FAILING TO IMPROVE AT REHAB AFTER A SEVERE INTRAVENTRICULAR BLEED. WERE THERE ANY ISSUES OR DIFFICULTIES DURING THE CERTAS SHUNT INSERTION/IMPLANTATION? DURING THE INITIAL SHUNT IMPLANTATION IN MID MARCH 22 THERE WERE NO ISSUES WITH THE PROCEDURE. WHAT WAS THE VALVE SETTING DURING THIS TIME? THE VALVE WAS PROGRAMMED TO A SETTING 4. WAS THERE CONFIRMATION OF THE SETTING BY RADIOGRAPH? NO NOT NEEDED AS VALVE WAS PROGRAMMED IN PACKET AND CONFIRMED WITH TOOLS AND CAN BE VISIBLY SEEN. IF APPLICABLE, WAS A MRI TAKEN AT ANYTIME AFTER THE CERTAS VALVE WAS IMPLANTED? IF SO, WAS THE VALVE SETTING CONFIRMED AFTER THE MR PROCEDURE? YES AT SOME STAGE THERE WAS IMAGING DONE. POST INITIAL IMPLANTATION OF VALVE THE PATIENT SIGNIFICANTLY IMPROVED. WAS THE SHUNT/VALVE WORKING WITHOUT ANY ISSUE UP UNTIL THE TIME OF THE EVENT? YES. THE PATIENT SHOWED SIGNIFICANT CLINICAL IMPROVEMENT POST IMPLANTATION. PLEASE EXPLAIN IN MORE DETAIL HOW THE PATIENT HAD BEEN SYMPTOMATIC FOR 1 WEEK (E.G. SIGNS/SYMPTOMS, VALVE SETTING AT THAT TIME, ANY SETTING CHANGES, ETC.) - THE PATIENT SHOWED SIGNIFICANT CLINICAL IMPROVEMENT POST IMPLANTATION. THE PATIENTS INITIAL PRESENTATION WAS FOR AN INTRAVENTRICULAR BLEED, AT THIS TIME HAD BILATERAL EVDS INSERTED. WHEN THE EVDS WERE READY FOR REMOVAL A CSF CULTURE WAS TAKEN WHICH WAS NEGATIVE FOR INFECTION. THE CP SHUNT WAS THEN IMPLANTED AT TIME OF SURGERY THE PATIENT HAD A FURTHER ROUTINE CSF CULTURE SENT WHICH CAME BACK POSITIVE. DECISION MADE TO LEAVE THE SHUNT INSITU AND TREAT THE PATIENT WITH SYSTEMIC ANTIBIOTICS WHICH WERE EFFECTIVE. THE SHUNT PERFORMED WELL FOR A FEW MONTHS AND THE PATIENT AGAIN BECAME UNWELL. THE DECISION WAS MADE TO REVISE THE SHUNT. AT THE TIME THE PATIENT UNDERWENT THE REVISION IT WAS APPARENT THE SIPHONGUARD HAD COMPLETELY DISLODGED FORM THE VALVE. A NEW CP SHUNT WAS THEN IMPLANTED AND SET TO A 4. POST THIS SECOND SHUNT THE PATIENT HAD A 4TH VENTRICULAR BLEED WHICH WAS UNRELATED TO THE SHUT IMPLANTATION. THE BLESS COMPRESSED ON THE BRAINSTEM AND THE PATIENT SUBSEQUENTLY PASSED AWAY. IF APPLICABLE, IF THE VALVE SETTING WAS CHANGED, WAS CONFIRMATION TAKEN BY RADIOGRAPH? NO. WHAT WERE THE INTERVENTIONS TAKEN DURING THIS 1 WEEKS¿ TIME (INCLUDE TROUBLESHOOTING MEASURES). AS ABOVE. PLEASE PROVIDE MORE DETAIL REGARDING THE ¿SEVERE INTRAVENTICULAR BLEED¿ (INCLUDING REASON, TREATMENT, ETC.) THE SEVERE INTRAVENTRICULAR BLEED WAS NOT RELATED TO THE SHUNT IMPLANTATION. IT WAS REPORTED THAT ¿THE PATIENT EVENTUALLY PASSED AWAY THE DAY AFTER THE SHUNT REVISION BUT NOT AS A RESULT OF THE HYDROCEPHALUS BUT BECAUSE OF A NEW BRAIN BLEED¿: A. DID THE PATIENT HAVE HYDROCEPHALUS DURING THAT TIME? YES. B. IS THE NEW BRAIN BLEED DIFFERENT FROM THE INTRAVENTICULAR BLEED DURING THE TIME HE WAS IN REHAB? THERE WERE 2 X BRAIN BLEEDS. INITIAL INTRAVENTRICULAR, SECOND 4TH VENTRICULAR. C. HOW MANY BLEEDS DID THE PATIENT SUFFER FROM? 2. D. LOCATION OF THE NEW BRAIN BLEED. 4TH VENTRICULAR. PLEASE EXPLAIN THE POSITION OF VALVE IN RELATION TO THE SCALP: A. WAS THE POSITION DIFFERENT FROM THE TIME IT WAS INITIALLY IMPLANTED? NO. B. CAN YOU PROVIDE A CLEARER IMAGE OF THE PICTURE PROVIDED SHOWING POSITION OF THE VALVE? NO. EXPLAIN IN MORE DETAIL HOW THE VALVE WAS BROKEN: THE SIPHONGUARD HAD COMPLETELY SHEARED AWAY FROM THE DISTAL PORTION OF THE VALVE MECHANISM. WHEN LOOKING AT IMAGING THE PATIENT DID APPEAR TO HAVE AN ODD SKULL CURVATURE. IT COULD BE POSSIBLE THAT THE DISTAL PORTION OF THE VALVE AT THE SIPHONGUARD WAS NOT SITTING FLUSH WITH THE BONE, AND THE IMPLANTATION SITE WAS A LITTLE LOWER THAN USUAL. WHEN REVISION SURGERY WAS PERFORMED THE SURGEON DID NOTICE THERE WAS EXCESSIVE TISSUE SITTING UNDER THE VALVE WHICH MAY HAVE CONTRIBUTED TO THE VALVE BEING SLIGHTLY FLEXED. THE PATIENT DID ALSO SUSTAIN A FALL WHILE IN THE BRAIN INJURY UNIT. HOW WAS THE SHUNT REVISED? (E.G. NEW CERTAS, OTHER SHUNT SYSTEM, ETC.) YES A SECOND CERTAS PLUS VALVE WAS IMPLANTED. PROVIDE PATIENT¿S CONDITION RIGHT AFTER THE REVISION TO THE TIME THE PATIENT DIED? UNSURE ARE AUTOPSY RESULTS AVAILABLE? NO. DOES THE PHYSICIAN ATTRIBUTE THE PATIENT¿S DEATH WITH THE CERTAS VALVE SHUNT SYSTEM? THE SURGEON HAS NOT SEEN A CERTAS VALVE BREAK BEFORE AND NOTED THAT ¿THE PATIENT EVENTUALLY PASSED AWAY THE DAY AFTER THE SHUNT REVISION BUT NOT AS A RESULT OF THE HYDROCEPHALUS BUT BECAUSE OF A NEW BRAIN BLEED¿. THE SURGEON DOES NOT ATTRIBUTE THE PATIENTS DEATH TO THE VALVE.
THE CERTAS VALVE (ID 828804) AS NOT RETURNED FOR EVALUATION BUT A PHOTO WAS PROVIDED SHOWING THE CUT/TEAR IN THE SILICONE HOUSING AROUND THE SIPHON GUARD COULD BE CONFIRMED. THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, IS PROBABLY DUE TO INFORMATION THAT INCLUDES THAT THE PATIENT HAD A FALL WHILE IN THE BRAIN INJURY UNIT. THE INTEGRA ACCOUNT MANAGER MENTIONED THERE IS A QUERY AS TO WHETHER THE PATIENT HIT THE VALVE AT THE SIPHONGUARD POINT WHEN THEY FELL AND WHETHER DUE TO EXCESSIVE SCARRED TISSUE IN THE PATIENTS ANATOMY THE VALVE WAS HYPERFLEXED IN SITU. AS REPORTED BY THE CUSTOMER, ALSO REPORTED ¿THE SURGEON DOES NOT ATTRIBUTE THE PATIENT¿S DEATH TO THE VALVE.¿
A FACILITY REPORTED A CERTAS VALVE (ID 828804) WAS IMPLANTED ON (B)(6) 2022. THE VALVE WAS BROKEN BETWEEN THE MECHANISM AND THE SIPHON GUARD AND WAS REVISED ON (B)(6) 2022, BUT THE PATIENT WAS SYMPTOMATIC FOR AT LEAST 1 WEEK PRIOR TO REVISION. PATIENT WAS FAILING TO IMPROVE AT REHABILITATION AFTER A SEVERE INTRAVENTRICULAR BLEED. THE PATIENT DIED THE DAY AFTER SHUNT REVISION. THE SURGEON HAS STATED ¿THE PATIENT EVENTUALLY PASSED AWAY THE DAY AFTER THE SHUNT REVISION BUT NOT AS A RESULT OF THE HYDROCEPHALUS BUT BECAUSE OF A NEW BRAIN BLEED¿.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1950062 | CERTAS INLIN VLV ONLY W/SPHNGD | CERTAS PLUS W/ SG | JXG | INTEGRA LIFESCIENCES SWITZERLAND SAR |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Death |