PIPELINE FLEX
Report
- Report Number
- 2029214-2026-00158
- Event Type
- Malfunction
- Date Received
- January 26, 2026
- Date of Event
- January 22, 2026
- Report Date
- May 8, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00763000277178
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5 UPDATED H6 UPDATED. BASED ON REVIEW OF EXISTING AND ADDITIONAL INFORMATION. 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: PED-500-18 (D061249). 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.
UPDATE B5 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 RECEIVED CLARIFIED THAT "STENT FELL OFF" MEANT THAT THE STENT WAS DETACHED FROM THE PUSHWIRE PREMATURELY, HOWEVER, THE EXACT TIMING IS UNKNOWN. THE CAUSE OF THE PED-475 DETACHMENT WAS NOT DETERMINED. THE CAUSE OF THE SUBOPTIMAL POSITIONING WAS NOT DETERMINED. THE CAUSE OF THE PED-500 FAILURE TO DEPLOY WAS NOT DETERMINED; THE OPERATOR IS AN EXPERIENCED SURGEON WHO HAS PERFORMED MORE THAN 100 PIPELINE DEPLOYMENTS. IT WAS REPORTED THAT THERE WAS SIGNIFICANT RESISTANCE IN THE DISTAL SECTION OF THE MICROCATHETER DURING THE DELIVERY PROCESS. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THE DISTAL TIP OF THE CATHETER EXHIBITED ACCORDION-LIKE DEFORMATION AFTER REMOVAL. THE PUSHWIRE WAS NOT ROTATED OR PULLED BACK AT ANYTIME DURING THE PROCEDURE. THE TIP END OF THE CATHETER WAS MOVED BECAUSE THE STENT WAS NOT FULLY OPENED AND COULD NOT ANCHOR TO THE VESSEL, HOWEVER, THE DEVICE DID NOT JUMP DURING DEPLOYMENT AND MULTIPLE PIPELINE DEVICES WERE NOT BEING USED WHEN MOVEMENT OCCURRED. IT WAS CLARIFIED THAT THE SURGERY WAS ULTIMATELY ABANDONED, AND THE PATIENT WAS RESCHEDULED FOR TREATMENT.
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ANEURYSM LOCATED AT LEFT OPHTHALMIC ARTERY WITH A MAX DIAMETER OF 5 MM AND A 3.5 MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. THE LANDING ZONE WAS 4.1MM DISTALLY AND 4.95MM PROXIMALLY. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. THE PRU LEVEL WAS WITHIN TARGET RANGE. IT WAS REPORTED THAT THE PED-475 STENT POSITION FOR DEPLOYMENT AND POSITIONING WAS SUBOPTIMAL, AND THE ENTIRE STENT FELL OFF. THE OPERATOR ATTEMPTED TO RETRIEVE THE ENTIRE STENT, BUT IT BECAME DISLODGED DURING THE RETRIEVAL PROCESS. THEN IT WAS REMOVED. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED THAT THE BLOOD FLOW WAS UNOBSTRUCTED. ANOTHER PED-500 STENT WAS USED, THE TIP END AND MID-SECTION OF THE STENT FAILED TO DEPLOY. DESPITE NUMEROUS REPEATED ATTEMPTS, DEPLOYMENT WAS STILL UNSUCCESSFUL. ULTIMATELY, THE PROCEDURE ENDED WITHOUT TREATMENT BEING PERFORMED. THE PIPELINE WAS USED FOR AN INDICATION THAT IS APPROVED (ON-LABEL). THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES INCLUDE A MARKSMAN MICROCATHETER (LOT#: 228123023), NAVIEN SHEATH (LOT#: B777521).
ADDITIONAL INFORMATION WAS RECEIVED. THE PIPELINE PED 500 WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN; RESHEATHING WAS THE ONLY ADDITIONAL MANEUVER ATTEMPTED, RESISTANCE WAS NOTED WITH THE PED 500 AT THE DISTAL END OF THE MICROCATHETER, ACCORDION DAMAGE TO THE MICROCATHETER WAS OBSERVED AFTER REMOVAL OF THE PED 500, AND THE CAUSES OF BOTH THE DELIVERY RESISTANCE AND THE MICROCATHETER DAMAGE COULD NOT BE DETERMINED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 80410 | PIPELINE FLEX | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED-475-20 | D042360 | 00763000277178 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |