UNKNOWN_NEUROVASCULAR_PRODUCT
Report
- Report Number
- 3012931345-2023-00007
- Event Type
- Injury
- Date Received
- January 18, 2023
- Date of Event
- November 28, 2021
- Report Date
- March 24, 2023
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- NRY
- PMA / PMN Number
- K133464
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
ALTHOUGH THE LOT NUMBER WAS NOT PROVIDED, THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED, AND IT COULD NOT BE DEFINITIVELY DETERMINED IF THE DEVICE FAILED TO MEET SPECIFICATIONS BECAUSE THE PRODUCT WAS NOT RETURNED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (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. BASED ON ADDITIONAL INFORMATION RECEIVED AS IT WAS REPORTED THAT, ON (B)(6) 2021, THE PATIENT EXPERIENCED A STROKE NIHSS =18, AT NANTES HOSPITAL NIHSS = 24. AFTER THROMBECTOMY NIHSS = 26. ON (B)(6) 2021, THE PATIENT EXPERIENCED A BRAIN EDEMA ON CONTROL CT SCAN WITH SUB-FACTORIAL COMMITMENT REQUIRING ASPEGIC 250MG IV. ADDITIONAL INFORMATION STATES THAT THERE WAS NO MALFUNCTION OF THE SUBJECT STENT OR ANY OTHER STRYKER DEVICE DURING THE PROCEDURE THAT CAUSED OR CONTRIBUTED TO THE CEREBRAL EDEMA. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THE COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT AND DOES NOT REQUIRE ESCALATION TO SENIOR MANAGEMENT, THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THIS EVENT.
B5 EXECUTIVE SUMMARY: UPDATED - RECEIVED ADDITIONAL INFORMATION ION 16-FEB-2023 INDICATED THAT THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 3. THE PATIENT CURRENT NEUROLOGICAL ASSESSMENT SHOWED THE MRS (MODIFIED RANKIN SCORE) OF 4 AND NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 20. FROM A MEDICAL STANDPOINT, THERE WAS NO MALFUNCTION OR ALLEGATION ALLEGED AGAINST THE SUBJECT STENT AND THE SUBJECT STENT WAS PERFORMED AS INTENDED.
THE SUBJECT DEVICE IS UNAVAILABLE TO MANUFACTURER.
IT WAS REPORTED THAT THE PATIENT¿S NEUROLOGICAL ASSESSMENT HAVING NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 18 WITH ATRIAL FIBRILLATION AND ARTERIAL HYPERTENSION HAD RECEIVED A MECHANICAL THROMBECTOMY RANDOMIZATION IN EXPERIMENTAL ARM ON (B)(6) 2021 USING THE SUBJECT STENT RETRIEVER. AT HOSPITAL, PATIENT NIHSS SCORE OF 24. ONE DAY POST THROMBECTOMY, COMPUTED TOMOGRAPHY (CT) SCAN BRAIN EDEMA WAS NOTED WITH NIHSS SCORE OF 26 REQUIRING ASPEGIC 250MG IV. THE PATIENT WAS RECOVERED WITH SEQUELAE FROM BRAIN EDEMA ON (B)(6) 2022 (76 DAYS AFTER THROMBECTOMY) WITH NIHSS SCORE OF 25 AT DISCHARGE. THE INVESTIGATOR ASSESSED ON BRAIN EDEMA AS NO REASONABLE POSSIBILITY RELATED TO THE STUDY PROCEDURE AS REASONABLE POSSIBILITY RELATED TO DISEASE UNDER STUDY. THE SPONSOR ASSESSED ON BRAIN EDEMA AS REASONABLE POSSIBILITY RELATED TO THE STUDY PROCEDURE (NIHSS INCREASED JUST AFTER THROMBECTOMY). NO OTHER INFORMATION WAS PROVIDED. UPDATED INFORMATION: RECEIVED ADDITIONAL INFORMATION ION 16-FEB-2023 INDICATED THAT THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 3. THE PATIENT CURRENT NEUROLOGICAL ASSESSMENT SHOWED THE MRS (MODIFIED RANKIN SCORE) OF 4 AND NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 20. FROM A MEDICAL STANDPOINT, THERE WAS NO MALFUNCTION OR ALLEGATION ALLEGED AGAINST THE SUBJECT STENT AND THE SUBJECT STENT WAS PERFORMED AS INTENDED.
IT WAS REPORTED THAT THE PATIENT¿S NEUROLOGICAL ASSESSMENT HAVING NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 18 WITH ATRIAL FIBRILLATION AND ARTERIAL HYPERTENSION HAD RECEIVED A MECHANICAL THROMBECTOMY RANDOMIZATION IN EXPERIMENTAL ARM ON (B)(6) 2021 USING THE SUBJECT STENT RETRIEVER. AT HOSPITAL, PATIENT NIHSS SCORE OF 24. ONE DAY POST THROMBECTOMY, COMPUTED TOMOGRAPHY (CT) SCAN BRAIN EDEMA WAS NOTED WITH NIHSS SCORE OF 26 REQUIRING ASPEGIC 250MG IV. THE PATIENT WAS RECOVERED WITH SEQUELAE FROM BRAIN EDEMA ON (B)(6) 2022 (76 DAYS AFTER THROMBECTOMY) WITH NIHSS SCORE OF 25 AT DISCHARGE. THE INVESTIGATOR ASSESSED ON BRAIN EDEMA AS NO REASONABLE POSSIBILITY RELATED TO THE STUDY PROCEDURE AS REASONABLE POSSIBILITY RELATED TO DISEASE UNDER STUDY. THE SPONSOR ASSESSED ON BRAIN EDEMA AS REASONABLE POSSIBILITY RELATED TO THE STUDY PROCEDURE (NIHSS INCREASED JUST AFTER THROMBECTOMY). NO OTHER INFORMATION WAS PROVIDED. UPDATED INFORMATION: RECEIVED ADDITIONAL INFORMATION ION 16-FEB-2023 INDICATED THAT THE MEDICAL PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF 3. THE PATIENT CURRENT NEUROLOGICAL ASSESSMENT SHOWED THE MRS (MODIFIED RANKIN SCORE) OF 4 AND NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 20. FROM A MEDICAL STANDPOINT, THERE WAS NO MALFUNCTION OR ALLEGATION ALLEGED AGAINST THE SUBJECT STENT AND THE SUBJECT STENT WAS PERFORMED AS INTENDED.
IT WAS REPORTED THAT THE PATIENT¿S NEUROLOGICAL ASSESSMENT HAVING NIHSS (NATIONAL INSTITUTE OF HEALTH STROKE SCALE) SCORE OF 18 WITH ATRIAL FIBRILLATION AND ARTERIAL HYPERTENSION HAD RECEIVED A MECHANICAL THROMBECTOMY RANDOMIZATION IN EXPERIMENTAL ARM ON (B)(6) 2021 USING THE SUBJECT STENT RETRIEVER. AT HOSPITAL, PATIENT NIHSS SCORE OF 24. ONE DAY POST THROMBECTOMY, COMPUTED TOMOGRAPHY (CT) SCAN BRAIN EDEMA WAS NOTED WITH NIHSS SCORE OF 26 REQUIRING ASPEGIC 250MG IV. THE PATIENT WAS RECOVERED WITH SEQUELAE FROM BRAIN EDEMA ON (B)(6) 2022 (76 DAYS AFTER THROMBECTOMY) WITH NIHSS SCORE OF 25 AT DISCHARGE. THE INVESTIGATOR ASSESSED ON BRAIN EDEMA AS NO REASONABLE POSSIBILITY RELATED TO THE STUDY PROCEDURE AS REASONABLE POSSIBILITY RELATED TO DISEASE UNDER STUDY. THE SPONSOR ASSESSED ON BRAIN EDEMA AS REASONABLE POSSIBILITY RELATED TO THE STUDY PROCEDURE (NIHSS INCREASED JUST AFTER THROMBECTOMY). NO OTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 15653 | UNKNOWN_NEUROVASCULAR_PRODUCT | CATHETER, THROMBUS RETRIEVER | NRY | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Male | Other| H | ACE68 (PENUMBRA). |