SURPASS EVOLVE 4.0MM X 17MM - IDE
Report
- Report Number
- 3008881809-2024-00404
- Event Type
- Injury
- Date Received
- September 9, 2024
- Date of Event
- July 13, 2023
- Report Date
- October 16, 2024
- Manufacturer
- STRYKER NEUROVASCULAR CORK
- Product Code
- OUT
- UDI-DI
- 07613327387810
- PMA / PMN Number
- P170024
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
THIS IS 2 OF 2 REPORTS (2ND MDR). H4 MANUFACTURING DATE ¿ ADDED. D4 EXPIRATION DATE - ADDED. D4 - GTIN - CORRECTED FROM '07613327387810' TO '(01)07613327387810(17)221231(10)22030091R'. PMA/510(K) - G4 - CORRECTED FROM 'P170024/S003' TO 'P170024'. F10 / H6 HEALTH IMPACT CODE GRID - HEALTH EFFECT - IMPACT CODE - UPDATED. DUE TO THE AUTOMATED MES (MANUFACTURING EXECUTION SYSTEM) SYSTEM 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 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. 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. INFORMATION STATES "THIS WAS NOT A MEDICAL INTERVENTION, BUT AN ADDITIONAL STENT WAS PLACED AS THE FIRST ONE DID NOT COMPLETELY COVER THE ANEURYSM NECK AS PER PROTOCOL. IT WAS PRE-PLANNED ADDITIONAL ". ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER INDICATED THAT THERE WAS AN ADVERSE CONSEQUENCE TO THE PATIENT. ¿PARENT ARTERY STENOSIS AND IN-STENT STENOSIS >50 TO <=75%¿. COVERAGE. BASED UPON MEDICAL REVIEW, THE HARM OBSERVED IN THIS COMPLAINT IS ANTICIPATED IN NATURE AS PER THE DEVICE RISK ASSESSMENT. AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITHIN THE DFU, PRODUCT LABELING AND/OR RISK DOCUMENTATION FILES, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THE REPORTED EVENT 'PATIENT PARENT VESSEL STENOSIS¿.
THIS IS 2 OF 2 REPORTS (2ND MDR).
CORE LAB DATA REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2022, THE SUBJECT STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT MIDDLE CEREBRAL ARTERY (M1 SEGMENT) ALONGSIDE A SECOND STENT. AT THE 12 MONTHS FOLLOW-UP ON (B)(6) 2023, DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING REVEALED PARENT ARTERY STENOSIS AND IN-STENT STENOSIS OF >50% TO <=75%. THE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE SUBJECT DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.
CORE LAB DATA REPORTED THAT DURING THE PROCEDURE ON (B)(6) 2022, THE SUBJECT STENT WAS SUCCESSFULLY DEPLOYED IN THE LEFT MIDDLE CEREBRAL ARTERY (M1 SEGMENT) ALONGSIDE A SECOND STENT. AT THE 12 MONTHS FOLLOW-UP ON (B)(6) 2023, DSA (DIGITAL SUBTRACTION ANGIOGRAPHY) IMAGING REVEALED PARENT ARTERY STENOSIS AND IN-STENT STENOSIS OF >50% TO <=75%. THE RELATIONSHIP BETWEEN THE ADVERSE EVENT AND THE SUBJECT DEVICE IS UNKNOWN. NO ADDITIONAL INFORMATION IS AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1601275 | SURPASS EVOLVE 4.0MM X 17MM - IDE | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | STRYKER NEUROVASCULAR CORK | 22030091R | 07613327387810 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 31 YR | Female | Other | EVOLVE STENT (STRYKER). |