UNKNOWN (SURPASS STREAMLINE)
Report
- Report Number
- 3008881809-2019-00258
- Event Type
- Malfunction
- Date Received
- September 3, 2019
- Date of Event
- August 21, 2019
- Report Date
- April 21, 2020
- Manufacturer
- STRYKER NEUROVASCULAR CORK
- Product Code
- OUT
- PMA / PMN Number
- P170024
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GB
- Reporter Occupation
- PHYSICIAN
Narratives
THE NEUROVASCULAR STRYKER SURPASS EVOLVE DEVICE IS NOT CURRENTLY NOT APPROVED OR COMMERCIALLY SOLD IN THE USA. THE EVENT FOR THE SURPASS EVOLVE DEVICE WAS FILED TO FDA AS A SIMILAR PRODUCT TO STRYKER DEVICE SURPASS STREAMLINE DEVICE THAT IS COMMERCIALLY AVAILABLE IN THE US (PMA # P170024). SEE SECTION 4.11.3 GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF, NOVEMBER 8, 2016.
B1: ADVERSE EVENT/PRODUCT PROBLEM: NOT APPLICABLE H1: TYPE OF REPORTABLE EVENT: NOT APPLICABLE DUE TO THE AUTOMATED MES SYSTEM THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE REPORTED EVENT IS COVERED IN THE DEVICE DFU. AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. AS PER THE ADDITIONAL INFORMATION,THE PATIENTS ANATOMY WAS SLIGHTLY TORTUOUS, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE FLOW DIVERTER WAS RETURNED WITH THE XT-27 MICROCATHETER, THE STENT WAS DEFORMED AND NOT FULLY OPENED AND THERE WAS KINKING NOTED TO THE RETURNED XT-27 MICROCATHETER. IT IS PROBABLE THAT THE XT-27 MICROCATHETER WAS KINKED DURING THE CLINICAL PROCEDURE CAUSING THE DEFORMATION TO THE FLOW DIVERTER STENT PREVENTING IT FROM FULLY OPENING WHEN ATTEMPTING TO DEPLOY. A ASSIGNABLE CAUSE OF CAUSED BY OTHER WILL BE ASSIGNED TO THE REPORTED AND ANALYSED EVENTS, AS THE INVESTIGATION INDICATES ANOTHER PRODUCT/DRUG/SUBSEQUENT PROCEDURE CAUSED THE ISSUE EVENT. NON-REPORTABLE RATIONALE: BASED ON FURTHER REVIEW, THE REPORTED EVENT DESCRIPTION, THE SUBJECT FLOW DIVERTER FAILED TO OPEN BUT WAS RECAPTURED BY THE OPERATOR AND SUCCESSFULLY REMOVED FROM THE PATIENT¿S BODY. THE PHYSICIAN DID NOT TAKE ANY ACTION/ INTERVENTION DUE TO THIS EVENT. THERE WAS NO REPORTED PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, NO MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE WAS PERFORMED AND THE EVENT WAS NOT LIFE THREATENING. THERE WAS NO INFORMATION TO REASONABLY SUGGEST THAT THIS TYPE OF MALFUNCTION WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE SUBJECT DEVICE.
THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THAT THE STENT WAS NOTED TO BE SLIGHTLY DEFORMED AND NOT OPEN FULLY AT THE DISTAL END. THE STENT DELIVERY WIRE (SDW) AND INTRODUCER SHEATH WERE NOT RETURNED. THE STRYKER XT-27 MICROCATHETER USED IN CONJUNCTION WITH THE STENT WAS RETURNED FOR ANALYSIS AND FOUND TO BE KINKED FROM THE DISTAL TIP. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS ONLY THE STENT WAS RETURNED. AS PER THE ADDITIONAL INFORMATION,THE PATIENTS ANATOMY WAS SLIGHTLY TORTUOUS, WHICH MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED ISSUE IS COVERED IN THE DEVICE DIRECTIONS FOR USE. THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT IT IS PROBABLE THAT THE XT- 27 MICROCATHETER WAS KINKED DURING THE CLINICAL PROCEDURE CAUSING THE DEFORMATION TO THE FLOW DIVERTER STENT PREVENTING IT FROM FULLY OPENING WHEN ATTEMPTING TO DEPLOY. THEREFORE, AN ASSIGNABLE CAUSE OF CAUSED BY OTHER DEVICE HAS BEEN ASSIGNED TO THIS EVENT.
IT WAS REPORTED THAT DURING PROCEDURE, THE STENT (SUBJECT DEVICE) FAILED TO OPEN AT THE DISTAL TIP. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
IT WAS REPORTED THAT DURING PROCEDURE, THE STENT (SUBJECT DEVICE) FAILED TO OPEN AT THE DISTAL TIP. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
IT WAS REPORTED THAT DURING PROCEDURE, THE STENT (SUBJECT DEVICE) FAILED TO OPEN AT THE DISTAL TIP. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
THE DEVICE IS NOT AVAILABLE TO THE MANUFACTURER.
IT WAS REPORTED THAT DURING PROCEDURE, THE STENT (SUBJECT DEVICE) FAILED TO OPEN AT THE DISTAL TIP. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 749189 | UNKNOWN (SURPASS STREAMLINE) | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | STRYKER NEUROVASCULAR CORK | 21516987 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | XT-27 MICROCATHETER (STRYKER) |