UNKNOWN (SURPASS STREAMLINE)
Report
- Report Number
- 3008881809-2019-00368
- Event Type
- Injury
- Date Received
- November 26, 2019
- Date of Event
- November 14, 2019
- Report Date
- January 22, 2020
- Manufacturer
- STRYKER NEUROVASCULAR CORK
- Product Code
- OUT
- PMA / PMN Number
- P170024
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
PRODUCT LONG DESCRIPTION: UNKNOWN (SURPASS STREAMLINE). CATALOG#: UNKNOWN. LOT/SERIAL NO.: UNKNOWN. 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.
H4 MANUFACTURING DATE ¿ ADDED D4 EXPIRATION DATE - ADDED THE SUBJECT DEVICE IS NOT AVAILABLE; THEREFORE, FUNCTIONAL TESTING AS WELL AS PHYSICAL ANALYSIS CANNOT BE PERFORMED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED AND IT CANNOT BE DETERMINED IF THE DEVICE MET SPECIFICATION, AS THE DEVICE WAS NOT RETURNED. 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 PATIENT¿S ANATOMY WAS SEVERELY TORTUOUS. THERE WAS A 2-HOUR DELAY. IT IS PROBABLE THAT THE TORTUOSITY OF THE PATIENT¿S ANATOMY CAUSED THE DIFFICULTIES IN CORRECTLY POSITIONING THE FLOW DIVERTER CAUSING THE SUBSEQUENT COMPLICATIONS. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED STENT MIGRATION, STENT IMPROPERLY DEPLOYED AND STENT FAILED/ UNABLE TO OPEN, AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED. IT CANNOT BE DEFINITIVELY DETERMINED IF THE APHASIA AND HEMIPARESIS ARE DIRECTLY RELATED TO THE DEVICE MALFUNCTION OR IF THEY ARE AN ANTICIPATED PROCEDURAL COMPLICATION, THEREFORE AN ASSIGNABLE CAUSE OF UNDETERMINABLE WILL BE ASSIGNED TO THE REPORTED PATIENT NEUROLOGICAL DEFICIT.
IT WAS REPORTED THAT DURING THE PROCEDURE, STENT PLACEMENT WAS FINISHED AND AFTER DEPLOYMENT OF THE SUBJECT FLOW DIVERTER STENT INSIDE THE PATIENT ANATOMY, 3D ROTATIONAL ANGIOGRAPHY SHOWED THAT THE SUBJECT DEVICE HAD TWISTED. THE TWIST WAS NOT VISIBLE AND NOT NOTICED BY THE PHYSICIANS BEFORE DEPLOYMENT. THE PHYSICIANS TRIED TO OPEN AND DILATE THE TWIST USING A BALLOON. THE PHYSICIANS TRIED TO RETRIEVE THE SUBJECT FLOW DIVERTER STENT BUT WERE NOT SUCCESSFUL. THE TWISTED AREA OF THE SUBJECT FLOW DIVERTER STENT WAS THEN OPENED WITH A BALLOON EXPANDING STENT. DUE TO THE TRIALS OF RETRIEVAL THE SUBJECT FLOW DIVERTER STENT LOST ITS DISTAL POSITION, SO THE PHYSICIAN PLACED A SECOND FLOW DIVERTER DISTAL TO THE INITIAL SUBJECT FLOW DIVERTER IN THE TELESCOPING TECHNIQUE. THIS RESULTED IN A TWO HOUR SURGICAL DELAY. THE PATIENT IS REPORTED TO HAVE DEVELOPED APHASIA AND HEMIPARESIS. NO FURTHER INFORMATION IS AVAILABLE.
IT WAS REPORTED THAT DURING THE PROCEDURE, STENT PLACEMENT WAS FINISHED AND AFTER DEPLOYMENT OF THE SUBJECT FLOW DIVERTER STENT INSIDE THE PATIENT ANATOMY, 3D ROTATIONAL ANGIOGRAPHY SHOWED THAT THE SUBJECT DEVICE HAD TWISTED. THE TWIST WAS NOT VISIBLE AND NOT NOTICED BY THE PHYSICIANS BEFORE DEPLOYMENT. THE PHYSICIANS TRIED TO OPEN AND DILATE THE TWIST USING A BALLOON. THE PHYSICIANS TRIED TO RETRIEVE THE SUBJECT FLOW DIVERTER STENT BUT WERE NOT SUCCESFUL. THE TWISTED AREA OF THE SUBJECT FLOW DIVERTER STENT WAS THEN OPENED WITH A BALLOON EXPANDING STENT. DUE TO THE TRIALS OF RETRIEVAL THE SUBJECT FLOW DIVERTER STENT LOST ITS DISTAL POSITION, SO THE PHYSICIAN PLACED A SECOND FLOW DIVERTER DISTAL TO THE INITIAL SUBJECT FLOW DIVERTER IN THE TELESCOPING TECHNIQUE. THIS RESULTED IN A TWO HOUR SURGICAL DELAY. THE PATIENT IS REPORTED TO HAVE DEVELOPED APHASIA AND HEMIPARESIS. NO FURTHER INFORMATION IS AVAILABLE.
LOT/SERIAL NO: UNKNOWN. 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 (B)(4). SUBJECT DEVICE IS NOT AVAILABLE.
IT WAS REPORTED THAT DURING THE PROCEDURE, STENT PLACEMENT WAS FINISHED AND AFTER DEPLOYMENT OF THE SUBJECT FLOW DIVERTER STENT INSIDE THE PATIENT ANATOMY, 3D ROTATIONAL ANGIOGRAPHY SHOWED THAT THE SUBJECT DEVICE HAD TWISTED. THE TWIST WAS NOT VISIBLE AND NOT NOTICED BY THE PHYSICIANS BEFORE DEPLOYMENT. THE PHYSICIANS TRIED TO OPEN AND DILATE THE TWIST USING A BALLOON. THE PHYSICIANS TRIED TO RETRIEVE THE SUBJECT FLOW DIVERTER STENT BUT WERE NOT SUCCESSFUL. THE TWISTED AREA OF THE SUBJECT FLOW DIVERTER STENT WAS THEN OPENED WITH A BALLOON EXPANDING STENT. DUE TO THE TRIALS OF RETRIEVAL THE SUBJECT FLOW DIVERTER STENT LOST ITS DISTAL POSITION, SO THE PHYSICIAN PLACED A SECOND FLOW DIVERTER DISTAL TO THE INITIAL SUBJECT FLOW DIVERTER IN THE TELESCOPING TECHNIQUE. THIS RESULTED IN A TWO HOUR SURGICAL DELAY. THE PATIENT IS REPORTED TO HAVE DEVELOPED APHASIA AND HEMIPARESIS. NO FURTHER INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1173431 | UNKNOWN (SURPASS STREAMLINE) | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | STRYKER NEUROVASCULAR CORK | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other| R | EXCELSIOR XT-27 MICROCATHETER (STRYKER)| EXCELSIOR XT-27 MICROCATHETER (STRYKER) |