TREVO XP PROVUE 4MM X 30MM
Report
- Report Number
- 3012931345-2020-00107
- Event Type
- Injury
- Date Received
- July 24, 2020
- Date of Event
- July 2, 2020
- Report Date
- June 14, 2022
- Manufacturer
- STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY
- Product Code
- NRY
- UDI-DI
- 00815742001853
- PMA / PMN Number
- K150616
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- ES
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
SECTION A: AGE AND GENDER: ADDED. SECTION B5: EXECUTIVE SUMMARY: UPDATED. SECTION D: CATALOG # SEARCH/ PRODUCT LONG DESCRIPTION/ CATALOG #/GIM SEARCH RESULTS/ LOT # / GTIN: UPDATED . SECTION G: PMA/510(K) - CORRECTED TO K150616 (AS THE CATALOG # OF THE DEVICE HAS BEEN UPDATED TO TREVO XP PROVUE RETRIEVER (4X30MM). SECTION D4 EXPIRATION DATE - ADDED. SECTION E: INITIAL REPORTER NAME/ INITIAL REPORTER FIRST NAME/ INITIAL REPORTER LAST NAME: ADDED . SECTION H4: MANUFACTURING DATE ¿ ADDED. BASED ON THE RESULTS OF THE DHR (DEVICE HISTORY RECORD) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THE SUBJECT DEVICE WAS NOT AVAILABLE; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. 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. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THE DEVICE WAS CONFIRMED TO BE IN GOOD CONDITION DURING PREPARATION AND WAS PREPARED AS PER THE DFU, CONTINUOUS FLUSH WAS MAINTAINED, AND THERE WAS MILD TORTUOSITY IN THE PATIENT'S ANATOMY. THE CAUSE OF THE ENT AND ITS RELATION TO THE SUBJECT DEVICE COULD NOT BE DEFINITIVELY DETERMINED. THE REPORTED 'PATIENT EMBOLUS' IS A KNOWN AND ANTICIPATED COMPLICATION TO THESE TYPES OF PROCEDURES AND PATIENT CONDITION AND IS LISTED AS SUCH IN THE DEVICE DIRECTIONS FOR USE. THEREFORE, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THIS EVENT.
B1 ADVERSE EVENT/PRODUCT PROBLEM: CORRECTED- NO ADVERSE EVENT. B2 OUTCOMES ATTRIBUTED TO AE : CORRECTED - NO OUTCOMES ATTRIBUTED TO AE. H1 TYPE OF REPORTABLE EVENT: CORRECTED - NO SERIOUS INJURY. DEVICE CODE GRID : CORRECTED: NO APPARENT ADVERSE EVENT. F10 / H6 HEALTH EFFECT - CLINICAL CODE: CORRECTED - NO HEALTH CONSEQUENCES OR IMPACT. F10 / H6 HEALTH EFFECT - IMPACT CODE: CORRECTED - NO 'UNEXPECTED MEDICAL INTERVENTION.' B5 EXECUTIVE SUMMARY: UPDATED. BASED ON ADDITIONAL INFORMATION RECEIVED ON 19-MAY-2022 FROM THE MEDICAL SAFETY INDICATED THAT THE EMBOLIZATION TO NEW TERRITORY WAS NOT RELATED TO STRYKER DEVICE. THEREFORE, THIS EVENT DOES NOT MEET REPORTING CRITERIA ANYMORE AND THE REPORTABILITY WILL BE CHANGED FROM REPORTABLE TO NON-REPORTABLE WITH A NEW AWARENESS DATE OF 19-MAY-2022. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE DEVICE IN QUESTION.
IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE WITH THE SUBJECT DEVICE (RETRIEVER), THE ENT (EMBOLIZATION TO NEW TERRITORY) WAS OBSERVED FROM PARIETAL BRANCH TO FRONTAL BRANCH OF MCA (MIDDLE CEREBRAL ARTERY) -M2 LEFT SIDE. ENT WAS TREATED AND TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF GRADE 3 IS ACHIEVED. NO OTHER INFORMATION WAS PROVIDED. UPDATED INFORMATION: ADDITIONAL INFORMATION RECEIVED 7/29/2020 INDICATED THAT THE EMBOLIZATION TO NEW TERRITORY WAS NOTICED DURING THE 4TH PASS. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 23 AND MRS (MODIFIED RANKIN SCORE) OF 0. AS THE INITIAL THROMBUS WAS IN M1 THE CLINIC WAS VERY EXTENSIVE (NIHSS 22). IT WAS A MIGRATION FROM A DISTAL EMBOLISM FROM PARIETAL M2 TO FRONTAL M2 FROM THE THIRD TO THE FOURTH PASS. THE PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO SIGNIFICANT CLINICAL VARIATIONS. 24 HOURS POST PROCEDURE, THE PATIENT WAS ASSESSED HAVING A NIHSS SCORE OF 22. THE PATIENT WAS DISCHARGED ON DAY 5-7 WITH NIHSS SCORE OF 22 AND MRS (MODIFIED RANKIN SCORE) OF 5. ON THE 90 DAY FOLLOW UP, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED MRS OF 4. ACCORDING TO THE PHYSICIAN, THE EMBOLIZATION TO NEW TERRITORY WAS PROBABLY RELATED TO THE DEVICE MOVED THE THROMBUS FROM ONE BRANCH TO ANOTHER.
IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE WITH THE SUBJECT DEVICE (RETRIEVER), THE ENT (EMBOLIZATION TO NEW TERRITORY) WAS OBSERVED FROM PARIETAL BRANCH TO FRONTAL BRANCH OF MCA (MIDDLE CEREBRAL ARTERY) -M2 LEFT SIDE. ENT WAS TREATED AND TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF GRADE 3 IS ACHIEVED. NO OTHER INFORMATION WAS PROVIDED. UPDATED INFORMATION: ADDITIONAL INFORMATION RECEIVED 7/29/2020 INDICATED THAT THE EMBOLIZATION TO NEW TERRITORY WAS NOTICED DURING THE 4TH PASS. PRE PROCEDURE, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED THE NATIONAL INSTITUTE OF HEALTH STROKE SCALE (NIHSS) OF 23 AND MRS (MODIFIED RANKIN SCORE) OF 0. AS THE INITIAL THROMBUS WAS IN M1 THE CLINIC WAS VERY EXTENSIVE (NIHSS 22). IT WAS A MIGRATION FROM A DISTAL EMBOLISM FROM PARIETAL M2 TO FRONTAL M2 FROM THE THIRD TO THE FOURTH PASS. THE PROCEDURE WAS COMPLETED AND THERE HAVE BEEN NO SIGNIFICANT CLINICAL VARIATIONS. 24 HOURS POST PROCEDURE, THE PATIENT WAS ASSESSED HAVING A NIHSS SCORE OF 22. THE PATIENT WAS DISCHARGED ON DAY 5-7 WITH NIHSS SCORE OF 22 AND MRS (MODIFIED RANKIN SCORE) OF 5. ON THE 90 DAY FOLLOW UP, THE PATIENT NEUROLOGICAL ASSESSMENT SHOWED MRS OF 4. ACCORDING TO THE PHYSICIAN, THE EMBOLIZATION TO NEW TERRITORY WAS PROBABLY RELATED TO THE DEVICE MOVED THE THROMBUS FROM ONE BRANCH TO ANOTHER. UPDATED INFORMATION #2 BASED ON ADDITIONAL INFORMATION RECEIVED ON 19-MAY-2022 FROM THE MEDICAL SAFETY INDICATED THAT THE EMBOLIZATION TO NEW TERRITORY WAS NOT RELATED TO STRYKER DEVICE. THEREFORE, THIS EVENT DOES NOT MEET REPORTING CRITERIA ANYMORE AND THE REPORTABILITY WILL BE CHANGED FROM REPORTABLE TO NON-REPORTABLE WITH A NEW AWARENESS DATE OF 19-MAY-2022.
THE SUBJECT DEVICE IS UNAVAILABLE TO MANUFACTURER.
IT WAS REPORTED THAT DURING THE THROMBECTOMY PROCEDURE WITH THE SUBJECT DEVICE (RETRIEVER), THE ENT (EMBOLIZATION TO NEW TERRITORY) WAS OBSERVED FROM PARIETAL BRANCH TO FRONTAL BRANCH OF MCA (MIDDLE CEREBRAL ARTERY) -M2 LEFT SIDE. ENT WAS TREATED AND TICI (THROMBOLYSIS IN CEREBRAL INFARCTION SCORE) OF GRADE 3 IS ACHIEVED. NO OTHER INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 782538 | TREVO XP PROVUE 4MM X 30MM | CATHETER, THROMBUS RETRIEVER | NRY | STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY | 90185 | 0000028441 | 00815742001853 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 56 YR | Male | Required Intervention| O |