PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2026-00044
- Event Type
- Malfunction
- Date Received
- January 9, 2026
- Date of Event
- December 30, 2025
- Report Date
- March 23, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00763000255152
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- 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.
CONTINUATION OF D10: PRODUCT ID: FG15150-0615-1S (LOT: 231572698); PRODUCT ID: PED2-450-20 (D007538); PRODUCT ID: PED2-500-25 (D022998). 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. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
PRODUCT ANALYSIS: AS FOUND CONDITION: THE PIPELINE FLEX SHIELD EMBOLIZATION DEVICE WAS RETURNED FOR ANALYSIS WITHIN SHIPPING BOX; AND WITHIN A PLASTIC BIO-POUCH. DAMAGE LOCATION DETAILS: NO BENT OR KINK WAS FOUND WITH PUSHWIRE. THE DISTAL HYPOTUBE AND PTFE SHRINK TUBING WERE FOUND TO BE INTACT WITH NO SIGNS OF ELONGATION. THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE FOUND TO BE INTACT. THE DPS SLEEVES WERE FOUND INTACT WITH NO SIGNS OF DAMAGE. NO DEFECTS WERE FOUND WITH THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, PADS OR WITH THE PROXIMAL BUMPER. THE BRAID WAS RETURNED ALREADY DETACHED FROM THE PUSHER; THEREFORE, THE PROXIMAL AND DISTAL ENDS COULD NOT BE IDENTIFIED. THE PIPELINE FLEX SHIELD BRAID WAS FOUND FULLY OPENED AND DAMAGED. NO OTHER ANOMALIES WERE OBSERVED. TESTING/ANALYSIS: N/A . CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX SHIELD WAS NOT CONFIRMED TO HAVE FAILURE TO OPEN AS THE PROXIMAL AS THE PIPELINE FLEX SHIELD BRAID WAS FOUND FULLY OPENED AND DAMAGED. HOWEVER, THE ROOT CAUSE OF DAMAGE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF ¿FAILURE/INCOMPLETE OPEN¿ INCLUDE VESSEL TORTUOSITY, DAMAGED BRAID, AND DEPLOYMENT OF THE BRAID IN THE VESSEL BEND. THE PIPELINE WAS POSITIONED IN A BEND. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE IT IS LIKELY THAT THE SEVERE VESSEL TORTUOSITY MAY HAVE CONTRIBUTED TO THE REPORTED ISSUES. 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.
ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE CAUSE OF THE EVENT WAS THOUGHT TO BE DUE TO THE TORTUOUS ANATOMY.
MEDTRONIC RECEIVED A REPORT THAT THE THREE PIPELINES FAILED TO OPEN; 1 DISTALLY, 1 PROXIMALLY, AND ONE BOTH DISTALLY AND PROXIMALLY. THE PATIENT WAS UNDERGOING TREATMENT FOR A RUPTURED, SACCULAR ANEURYSM LOCATED IN THE LEFT OPHTHALMIC ICA. THE MAX DIAMETER WAS ~2.3MM, AND THE NECK DIAMETER WAS ~2.4MM. THE LANDING ZONE WAS ~4.3MM DISTAL AND ~4.6MM PROXIMAL. THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED AND THE PRU LEVEL WAS 230. THE ACCESS VESSEL WAS THE LEFT ICA, WHICH WAS ~4.7MM IN DIAMETER. IT WAS REPORTED THAT THE PARENT VESSEL DIAMETER WAS INITIALLY MEASURED AT APPROXIMATELY 4.6 MM IN THE WORKING PROJECTION. BASED ON THIS MEASUREMENT, A 4.5 × 25 FLOW DIVERTER WAS SELECTED. DURING DEPLOYMENT, THE DISTAL END FAILED TO ACHIEVE ADEQUATE WALL APPOSITION. RE-SHEATHING AND REDEPLOYMENT WERE ATTEMPTED; HOWEVER, DISTAL MALAPPOSITION PERSISTED. THE VESSEL WAS THEN RE-MEASURED IN AN ALTERNATE ANGIOGRAPHIC PROJECTION, WHERE THE DIAMETER APPEARED TO BE APPROXIMATELY 4.7 MM. BASED ON THIS REASSESSMENT, A 5 × 25 FLOW DIVERTER WAS SELECTED. DURING DEPLOYMENT, THIS DEVICE DEMONSTRATED SIMILAR BEHAVIOR, WITH PERSISTENT DISTAL MALAPPOSITION. AFTERWARDS, THE ATTEMPTED WITH A 5X20 FLOW DIVERTER, WHICH DID OPEN DISTALLY BUT FAILED TO OPEN PROXIMALLY. TO NOTE, THERE WERE TWO SHARP BENDS. FURTHER CORRECTIVE STRATEGIES WERE ATTEMPTED, INCLUDING: DEPLOYMENT IN A STRAIGHTER VESSEL SEGMENT AND ATTEMPTED OPENING IN THE MCA AND USING OF THE DRAG-AND-PULL TECHNIQUE. DESPITE THESE MANEUVERS, ADEQUATE DISTAL WALL APPOSITION COULD NOT BE ACHIEVED. THE PROCEDURE WAS ABANDONED. THE PATIENT DID NOT EXPERIENCE ANY INJURY OR COMPLICATIONS. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). LESS THAN 50% HAD BEEN DEPLOYED AND THE SECOND PIPELINE WAS NOT POSITIONED IN A BEND WHEN IT FAILED TO OPEN. THE THIRD PIPELINE WAS POSITIONED IN A BEND, AND MORE THAN 50% HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINES HAD B EEN RESHEATHED 2 OR LESS TIMES. IT WAS NOTED THAT THE SECOND PIPELINE ALSO FAILED TO OPEN PROXIMALLY. ANCILLARY DEVICES INCLUDE A NEURONMAX SHEATH, NEURON GUIDE CATHETER, TRAXCESS GUIDEWIRE, AND PHENOM 27 MICROCATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 89055 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-500-20 | D047942 | 00763000255152 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 41 YR | Male | SEE H11... |