PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2025-02436
- Event Type
- Malfunction
- Date Received
- November 18, 2025
- Date of Event
- November 14, 2025
- Report Date
- January 28, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00763000284718
- 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.
CONTINUATION OF D10: PRODUCT ID FA-55150-1030 (LOT: 229008946); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID RFX058-115-08 (LOT: B771489); IMPLANT DATE N/A; EXPLANT DATE N/A PRODUCT ID 103-0606-200 (LOT: B797193); IMPLANT DATE N/A; EXPLANT DATE N/A. 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: ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE. 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 SHIELD EMBOLIZATION DEVICE AND MARKSMAN CATHETER WERE RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX; AND WITHIN A PLASTIC BIO-POUCH. THE PIPELINE FLEX SHIELD WAS RETURNED OUTSIDE THE MARKSMAN CATHETER. ¿ 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 PROXIMAL BUMPER, RE-SHEATHING PAD, RE-SHEATHING MARKER, DISTAL MARKER, AND TIP COIL. THE BRAID WAS RETURNED ALREADY DETACHED FROM THE PUSHER; THEREFORE, THE PROXIMAL AND DISTAL ENDS COULD NOT BE IDENTIFIED. THE PIPELINE FLEX SHIELD BRAID ENDS WERE FOUND TO BE FULLY OPENED AND DAMAGED. NO FLASH OR VOIDS MOLDED WERE OBSERVED IN THE HUB. NO DAMAGE WAS FOUND WITH HUB. THE CATHETER BODY WAS FOUND TO BE ACCORDIONED FROM ~9.8CM TO ~8.5CM FROM DISTAL END. NO DAMAGE WAS FOUND WITH MARKSMAN CATHETER DISTAL TIP/MARKER BAND. NO OTHER ANOMALIES WERE OBSERVED. ¿ TESTING/ANALYSIS: THE TOTAL AND USABLE LENGTHS OF MARKSMAN CATHETER WERE MEASURED TO BE WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND WATER EXITED OUT OF 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 ISSUES; HOWEVER, THE RESISTANCE OBSERVED AT THE DAMAGED LOCATIONS. ¿ CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX SHIELD AND MARKSMAN CATHETER WERE CONFIRMED TO HAVE RESISTANCE AS THE PIPELINE FLEX SHIELD BRAID AND MARKSMAN CATHETER WERE FOUND TO BE DAMAGED. POSSIBLE CAUSES INCLUDE INCOMPATIBLE CATHETER, DAMAGED CATHETER, BURRS, BUMPS, KINKS OR OTHER DAMAGE ON PED OR PUSHWIRE, FRAYED ENDS ON BRAID, PATIENT VESSEL TORTUOSITY, USER DOES NOT MAINTAIN CONTINUOUS FLUSH, AND USERS PULLS BACK ON/TORQUES WIRE WHILE ADVANCING PED IN MICROCATHETER. THE MARKSMAN CATHETER IS COMPATIBLE TO USE WITH PIPELINE FLEX, THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE AND A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. WHICH ELIMINATES THESE FACTORS OUT AS POTENTIAL CAUSES. HOWEVER, BASED ON THE ANALYSIS FINDING, THE PIPELINE FLEX SHIELD COULD NOT BE CONFIRMED TO HAVE FAILURE TO OPEN AT DISTAL AS THE DEVICE WAS RESHEATED. IN ADDITION, THE PIPELINE FLEX BRAID ENDS WERE FOUND FULLY OPENED AND DAMAGED. POSSIBLE CAUSES OF ¿FAILURE/INCOMPLETE OPEN¿ INCLUDE VESSEL TORTUOSITY, DAMAGED BRAID, AND DEPLOYMENT OF THE BRAID IN THE VESSEL BEND. HOWEVER, THE CUSTOMER INDICATED THAT VESSEL TORTUOSITY WAS MODERATE, AND THE BRAID WAS NOT POSITIONED IN THE VESSEL BEND, WHICH ELIMINATES THESE FACTORS OUT AS POTENTIAL CAUSES. 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 FAILURE TO OPEN/PIPELINE DAMAGE WAS NOT DETERMINED. RESISTANCE WAS ENCOUNTERED DURING DELIVERY. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. NO DAMAGE TO THE PIPELINE PUSHWIRE OR CATHETER WAS OBSERVED. THE PIPELINE HAD NOT BEEN PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE. FOR THE SECOND PIPELINE STENT, THE PUSHING AND PULLING WAS DONE BECAUSE THE DEVICE FAILED TO OPEN.
MEDTRONIC RECEIVED A REPORT THAT THE PIPELINE HAD FAILED TO OPEN IN THE DISTAL SECTION AND WAS FOUND TO HAVE FRAYED EDGES. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED ANEURYSM LOCATED IN THE C6 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY WITH A MAX DIAMETER OF 3.4 MM AND A 2.6 MM NECK DIAMETER. LANDING ZONE: DISTAL: 4.5 MM AND PROXIMAL: 4.9 MM. THE ACCESSED VESSEL WAS THE RIGHT FEMORAL ARTERY WITH A DIAMETER OF 7 MM. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT WAS ADMINISTERED. THE PRU LEVEL WAS 2. THE ANGIOGRAPHIC RESULT POST PROCEDURE SHOWED RIGHT INTERNAL CAROTID ARTERY C6 SEGMENT ANEURYSM. IT WAS REPORTED THAT FOR PREOPERATIVE PREPARATION, AN 8F TERUMO FEMORAL SHEATH WAS USED FOR PUNCTURE, WITH THE RIGHT FEMORAL ARTERY AS THE PUNCTURE SITE. AS THE PATIENT HAD PREVIOUSLY UNDERGONE ANGIOGRAPHY, A 5F MPA LONG SINGLE-CURVE CATHETER WAS DIRECTLY USED TO GUIDE THE LEE KAI MEDICAL 8F DELIVERY CATHETER (PICA8F90MPS) TO THE RIGHT C1 SEGMENT. THE EV3 INTRACRANIAL SUPPORT CATHETER (5F NAVIEN, RFX058-115-08, LOT NUMBER: B771489) WITH INTACT PACKAGING WAS OPENED, AND WATER INJECTION SHOWED NO ISSUES. AFTER CONNECTING TO DRIP INFUSION, THE LOACH GUIDEWIRE WAS USED TO ADVANCE THE EV3 INTRACRANIAL SUPPORT CATHETER (5F NAVIEN, RFX058-115-08, LOT NUMBER: B771489) TO THE C4 SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY. THE LOACH GUIDEWIRE WAS WITHDRAWN, AND THREE-DIMENSIONAL ANGIOGRAPHY WAS PERFORMED. AFTER ANGIOGRAPHY WAS COMPLETED, THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229008946) WITH INTACT PACKAGING WAS OPENED, AND WATER FLUSHING WAS PERFORMED TO CHECK THE CATHETER; NO ISSUES WERE FOUND. USING THE EV3 GUIDEWIRE (AVIGO, 103-0606-200, LOT NUMBER: B797193), THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229008946) WAS ADVANCED TO THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY. THE EV3 GUIDEWIRE (AVIGO, 103-0606-200, LOT NUMBER: B797193) WAS THEN WITHDRAWN. THE EV3 FLOW-DIV ERTING STENT (PIPELINE¿ SHIELD, PED2-500-18, LOT NUMBER: D057463) WITH INTACT PACKAGING WAS OPENED AND SUBSEQUENTLY HYDRATED. THE HYDRATED EV3 FLOW-DIVERTING STENT (PIPELINE¿ SHIELD, PED2-500-18, LOT NUMBER: D057463) WAS THEN ADVANCED INTO THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229008946). THE STENT WAS SLOWLY DELIVERED OUT OF THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229008946). THE STENT DELIVERY WIRE WAS ADVANCED PAST THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY, AND THE DISTAL TIP OF THE STENT WAS OPENED AND DEPLOYED AT THE M1 SEGMENT. THE STENT WAS THEN PULLED BACK TOWARD THE INTERNAL CAROTID ARTERY. DESPITE SEVERAL ATTEMPTS, THE DISTAL TIP COULD NOT BE OPENED. AFTER MULTIPLE ATTEMPTS, THE STENT WAS EVENTUALLY OPENED; HOWEVER, ANGIOGRAPHY REVEALED THAT THE DISTAL TIP OF THE STENT WAS FATIGUED AND HAD BURRS, AND THE STENT BODY WAS DEFORMED. FOR SURGICAL SAFETY, THE OPERATOR REPLACED THE STENT WITH A NEW ONE. THE EV3 FLOW-DIVERTING STENT (PIPELINE¿ SHIELD, PED2-500-18, LOT NUMBER: D057463) WAS RETRACTED INTO THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229008946), AND BOTH WERE WITHDRAWN FROM THE BODY TOGETHER. OUTSIDE THE BODY, THE EV3 FLOW-DIVERTING STENT (PIPELINE¿ SHIELD, PED2-500-18, LOT NUMBER: D057463) WAS PUSHED OUT OF THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229008946) FOR INSPECTION. IT WAS OBSERVED THAT THE DISTAL TIP OF THE STENT WAS FATIGUED AND HAD BURRS, AND THE OVERALL SHAPE OF THE STENT WAS DEFORMED. EVEN WHEN DEPLOYED OUTSIDE THE BODY, THE DISTAL TIP COULD NOT BE OPENED. A NEW EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229570593) WITH INTACT PACKAGING WAS THEN REPLACED AND INSPECTED, SHOWING NO ISSUES. AFTER CONNECTING TO DRIP INFUSION, THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229570593) WAS GUIDED TO THE M1 SEGMENT OF THE RIGHT MIDDLE CEREBRAL ARTERY USING THE EV3 GUIDEWIRE (AVIGO, 103-0606-200, LOT NUMBER: B797193). THE EV3 FLOW-DIVERTING STENT (PIPELINE¿ SHIELD, PED2-500-20, LOT NUMBER: D058265) WITH INTACT PACKAGING WAS THEN OPENED AND HYDRATED. AFTER HYDRATION, THE STENT WAS SLOWLY ADVANCED INTO THE EV3 CATHETER (MARKSMAN, FA-55150-1030, LOT NUMBER: 229570593). UNDER FLUOROSCOPIC GUIDANCE, THE STENT WAS GRADUALLY DELIVERED TO THE M1 SEGMENT OF THE MIDDLE CEREBRAL ARTERY FOR DEPLOYMENT. THROUGH A COMBINATION OF PUSHING AND PULLING, THE DISTAL TIP OF THE STENT WAS SLOWLY OPENED, AND THE STENT WAS THEN GENTLY REPOSITIONED TO THE C7 SEGMENT FOR FURTHER DEPLOYMENT. ONCE THE STENT WAS RETRACTED TO THE C7 SEGMENT, THE DISTAL TIP OPENED. THE STENT WAS SUBSEQUENTLY SLOWLY DRAWN TO THE AREA BELOW THE POSTERIOR COMMUNICATING ARTERY AND GRADUALLY DEPLOYED TO THE C6 AND C5 SEGMENTS. BY UTILIZING THE STENT¿S TENSION, THE EV3 FLOW-DIVERTING STENT (PIPELINE¿ SHIELD, PED2-500-20, LOT NUMBER: D058265) WAS DEPLOYED STEP BY STEP, AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. IT WAS REPORTED THE MARKSMAN CATHETER ENCOUNTERED RESISTANCE IN THE MIDDLE SECTION. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS OFF-LABEL. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER WAS FLUSHED AS INDICATED IN THE IFU. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A NAVIEN GUIDE CATHETER AND AVIGO GUIDEWIRE.
ADDITIONAL INFORMATION WAS RECEIVED THAT FOR THE SECOND PIPELINE, THE DISTAL SECTION DID NOT OPEN. THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE INCLUDED PUSHING THE STENT GUIDEWIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1864033 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-500-18 | D057463 | 00763000284718 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Male | SEE H11. |