CERTAS INLIN VLV ONLY W/SPHNGD
Report
- Report Number
- 3013886523-2022-00050
- Event Type
- Death
- Date Received
- February 16, 2022
- Date of Event
- January 14, 2022
- Report Date
- April 12, 2022
- Manufacturer
- INTEGRA LIFESCIENCES SWITZERLAND SAR
- Product Code
- JXG
- UDI-DI
- 10886704071365
- PMA / PMN Number
- K143111
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
THE CERTAS VALVE (ID 828804) WAS NOT RETURNED FOR EVALUATION AS THE PRODUCT IS NOT AVAILABLE FOR RETURN AS PER CUSTOMER; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. ACCORDING TO INTEGRA'S MEDICAL SAFETY ASSESSMENT: BASED ON THE COMPLAINT INFORMATION A CAUSAL RELATIONSHIP BET WEEN THE DEVICE AND THE DEMISE OF THE PATIENT IS INCONCLUSIVE WITHOUT INTERNAL INVESTIGATION OF THE DEVICE. IT APPEARS TO HAVE BEEN AN OVER DRAINAGE SCENARIO RESULTING FROM THE CHANGE OF THE CERTAS SETTINGS FROM 5 TO 4 WITHOUT RADIOGRAPHIC CONFIRMATION. THE ELECTRONIC PROGRAMMER WAS USED TO ADJUST AND VERIFY VALVE SETTINGS, AS IT IS CUSTOMARY PRACTICE THAT RADIOGRAPHS BE TAKEN TO CONFIRM THE PATIENT'S STATUS AND VALVE SETTINGS. AS STATED IN THE INSTRUCTIONS FOR USE (IFU), "ADJUSTING THE VALVE TO A PERFORMANCE SETTING THAT IS LOWER THAN NECESSARY CAN LEAD TO EXCESSIVE CSF DRAINAGE WHICH CAN CAUSE SUBDURAL HEMATOMAS" .
2 OF 2 REPORTS. SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00049. A FACILITY REPORTED A CERTAS PLUS VALVE (ID (828804) WAS IMPLANTED WITH A BACTISEAL CATHETER (ID (82072) VIA V-P SHUNT WITH SETTING AT 5 ON (B)(6) 2021, TO TREAT HYDROCEPHALUS. THE PATIENT IS A (B)(6) MALE WITH RELEVANT MEDICAL HISTORY OF CARDIAC COMORBIDITIES, PERIPHERAL VASCULAR DISEASE, ON ASPIRIN AND CLOPIDOGREL. TWO DAYS LATER, THE VALVE SETTING WAS CHANGED TO 4. NO X-RAY WAS TAKEN FOR CONFIRMATION AFTER THE SETTING CHANGE; HOWEVER, IT WAS CONFIRMED WITH THE ELECTRONIC PROGRAMMER AND CONFIRMED AGAIN IN THE CLINIC 2 WEEKS LATER. THE PATIENT DID NOT HAVE ANY MRI PROCEDURES AFTER THE SHUNT VALVE SYSTEM WAS IMPLANTED ON (B)(6) 2021. THE PATIENT DEVELOPED A SUBDURAL (BLOOD CLOT BETWEEN THE BRAIN AND DURA ON THE LEFT SIDE) ON THE OPPOSITE SIDE OF THE SHUNT AND ON (B)(6) 2022, THE PATIENT DIED. THE CAUSE OF DEATH WAS RULED AS ACUTE SUBDURAL BLEED ON THE LEFT SIDE.
2 OF 2 REPORTS. SAME PATIENT, SAME EVENT, DIFFERENT PRODUCTS. OTHER MFG REPORT NUMBER: 3013886523-2022-00049. A FACILITY REPORTED A CERTAS PLUS VALVE (ID (828804) WAS IMPLANTED WITH A BACTISEAL CATHETER (ID (82072) VIA V-P SHUNT WITH SETTING AT 5 ON (B)(6) 2021, TO TREAT HYDROCEPHALUS. THE PATIENT IS A (B)(6) MALE WITH RELEVANT MEDICAL HISTORY OF CARDIAC COMORBIDITIES, PERIPHERAL VASCULAR DISEASE, ON ASPIRIN AND CLOPIDOGREL. TWO DAYS LATER, THE VALVE SETTING WAS CHANGED TO 4. NO X-RAY WAS TAKEN FOR CONFIRMATION AFTER THE SETTING CHANGE; HOWEVER, IT WAS CONFIRMED WITH THE ELECTRONIC PROGRAMMER AND CONFIRMED AGAIN IN THE CLINIC 2 WEEKS LATER. THE PATIENT DID NOT HAVE ANY MRI PROCEDURES AFTER THE SHUNT VALVE SYSTEM WAS IMPLANTED ON (B)(6) 2021. THE PATIENT DEVELOPED A SUBDURAL (BLOOD CLOT BETWEEN THE BRAIN AND DURA ON THE LEFT SIDE) ON THE OPPOSITE SIDE OF THE SHUNT AND ON (B)(6) 2022, THE PATIENT DIED. THE CAUSE OF DEATH WAS RULED AS ACUTE SUBDURAL BLEED ON THE LEFT SIDE.
N/A.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 4268 | CERTAS INLIN VLV ONLY W/SPHNGD | CERTAS PLUS W/ SG | JXG | INTEGRA LIFESCIENCES SWITZERLAND SAR | 4837624 | 10886704071365 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Death |