PIPELINE FLEX
Report
- Report Number
- 2029214-2024-02176
- Event Type
- Malfunction
- Date Received
- November 22, 2024
- Date of Event
- November 20, 2024
- Report Date
- February 3, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
PRODUCT ANALYSIS: AS FOUND CONDITION: THE PIPELINE FLEX BRAID AND PHENOM 27 CATHETER WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; WITHIN A PLASTIC BIO-POUCH; AND WITHIN AN OPENED PHENOM 27 INNER POUCH. THE PIPELINE FLEX PUSHWIRE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, ANY CONTRIBUTING FACTORS COULD NOT BE ASSESSED. ¿DAMAGE LOCATION DETAILS: THE BRAID WAS RETURNED ALREADY DETACHED FROM THE PUSHER; THEREFORE, THE PROXIMAL AND DISTAL ENDS COULD NOT BE IDENTIFIED. THE PIPELINE FLEX BRAID ENDS WERE FOUND TO BE FULLY OPENED AND DAMAGED. NO FLASH OR VOIDS MOLDED WERE OBSERVED IN THE HUB. NO BENT OR KINK WAS FOUND WITH CATHETER BODY. THE CATHETER TIP AND MARKER BAND WERE EXAMINED; AND NO DAMAGE WAS FOUND. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS: THE TOTAL AND USABLE LENGTHS OF THE CATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND WATER EXITED OUT FROM THE DISTAL TIP. THE CATHETER WAS THEN TESTED BY RUNNING AN IN-HOUSE 0.0265¿ MANDREL THROUGH CATHETER TIP AND HUB. THE MANDREL SUCCESSFULLY PASSED THROUGH THE CATHETER HUB AND TIP WITH NO ISSUE. CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX WAS NOT CONFIRMED TO HAVE FAILURE TO OPEN AT THE DISTAL AS THE PIPELINE FLEX BRAID WAS FOUND TO BE FULLY OPENED AND DAMAGED. DAMAGE TO THE BRAID IDENTIFIED DURING ANALYSIS, COULD HAVE OCCURRED DUE TO RESHEATHING OF THE PIPELINE FLEX MORE THAN TWO TIMES. IN ADDITION, BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX WAS NOT CONFIRMED TO HAVE RESISTANCE AS THE PIPELINE FLEX PUSHWIRE WAS NOT RETURNED FOR ANALYSIS. THEREFORE, ANY CONTRIBUTING FACTORS COULD NOT BE ASSESSED. NO DEFECT WAS FOUND WITH RETURNED PHENOM 27 CATHETER. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
H3: DEVICE RECEIVED. ANALYSIS IS IN PROGRESS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC RECEIVED A REPORT THAT A PIPELINE FAILED TO OPEN AT THE DISTAL END AND COULD NOT BE RETRIEVED. CATHETER RESISTANCE WAS ENCOUNTERED AT THE DISTAL END OF THE CATHETER. THE REPORTED DEVICE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTION FOR USE (IFU). THE PATIENT WAS BEING TREATED FOR AN UNRUPTURED C3 DISSECTING ANEURYSM WITH A FUSIFORM MORPHOLOGY. ANEURYSM DIMENSIONS: MAX DIAMETER 5 MM AND NECK DIAMETER 4 MM. LANDING ZONE (ARTERY SIZE): DISTAL 4.1 MM AND PROXIMAL 4.8 MM. THE PATIENT¿S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE FEMORAL ARTERY (9 MM DIAMETER). THE DISTAL END OF THE DENSE MESH STENT COULDN'T BE OPENED OR RETRIEVED. THE WHOLE SYSTEM WAS REMOVED TOGETHER. DAPT (DUAL ANTIPLATELET TREATMENT) WAS ADMINISTERED (PRU LEVEL QUALIFIED). THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS SMOOTH BLOOD FLOW. THE PIPELINE WAS NOT POSITIONED IN A BEND. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. THE PIPELINE WAS REMOVED FROM PATIENT. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT THEY REPLACED THE STENT WITH A SMALLER ONE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE CAUSE OF THE PIPELINE FAILURE/RESISTANCE WAS NOT DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1852951 | PIPELINE FLEX | LASER THERAPY PRODUCT | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED-475-25 | B570211 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | Female |