PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2025-02561
- Event Type
- Malfunction
- Date Received
- December 8, 2025
- Date of Event
- December 4, 2025
- Report Date
- March 2, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00847536002548
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- 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: ISF-080-050 (LOT: B806637); IMPLANT DATE N/A; EXPLANT DATE N/A. PRODUCT ID: PED2-450-16 (D003969). PRODUCT ID: PED2-400-10 (D006277). 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 WAS RECEIVED. FOR THE ARTISSE ISF-080-050 (LOT: B806637); THERE WAS NO VISIBLE PACKAGING DAMAGE OR ABNORMALITIES WITH THE DEVICE BEFORE OPENING. VISUAL CONFIRMATION OF THE DEVICE SEATING IN THE MICROCATHETER HUB BEFORE LOADING WAS UNCERTAIN; HOWEVER, THIS IS UNLIKELY SINCE THE DEVICE WAS FOUND COMPLETELY BENT, SUGGESTING IT WAS NOT CORRECTLY SEATED AND LOADED. FORCE WAS REQUIRED TO ATTEMPT LOADING THE DEVICE INTO THE MICROCATHETER HUB, WHICH CAUSED THE KINKING. THE CATHETER USED WAS NOT A MEDTRONIC DEVICE, BUT A HEADWAY 21. NO OTHER ISSUES WERE NOTED WITH THE MICROCATHETER DURING THE LOADING ATTEMPTS. FOR THE PED2-450-18 (LOT: D003161); DISSATISFACTION WITH DISTAL OPENING WAS RELATED TO INCOMPLETE EXPANSION OF THE DEVICE AND CHALLENGES WITH ACCESS AND SUPPORT WHILE ATTEMPTING TO LOAD THE STENT ON A CURVE, WHICH CAUSED THE DEVICE TO CONTINUALLY BULGE INTO THE ANEURYSM SAC. THERE WAS DIFFICULTY RECAPTURING THE DISTAL END DURING RECAPTURE ATTEMPTS. AFTER THE ACCESS SYSTEM FELL BACK, AN ARISTOTLE 24 WIRE WAS USED FOR R E-NAVIGATION WITHOUT ANY REPORTED COMPLICATIONS. THE PIPELINE WAS ONLY PARTIALLY DEPLOYED AT THE TIME OF MIGRATION, AFTER WHICH RECAPTURE WAS ATTEMPTED AND THE STENT WAS ULTIMATELY DEPLOYED INTO A SHEATH. FOR PED2-450-16 (LOT: D003969); DISTAL FORESHORTENING WAS A TTRIBUTED TO TENSION BUILD-UP IN THE MID SEGMENT OF THE STENT, WHICH RELAXED AFTER PROXIMAL DEPLOYMENT. THE PROXIMAL END WAS DEPLOYED VERY PROXIMALLY, RESULTING IN FORESHORTENING AT THE DISTAL END. THERE WAS DIFFICULTY DEPLOYING THE STENT ON A CURVE, PRIMARILY DUE TO POOR ACCESS SUPPORT AND A VERY TORTUOUS CAROTID LOOP. THERE IS NO MENTION OF PATIENT SYMPTOMS OR THE NEED FOR FURTHER INTERVENTION RESULTING FROM THE FORESHORTENING OR THE NEED FOR AN ADDITIONAL STENT. FOR PED2-400-10 (LOT: D006277); RECANNULATION AFTER LOSING ACCESS WITH THE DEVICE STILL LOADED WAS PREVENTED BECAUSE THE PHYSICIAN BELIEVED THAT VESSEL TORTUOSITY HAD CAUSED BRAID RIBBONING, MAKING IT IMPOSSIBLE TO CORRECTLY APPOSE THE DEVICE TO THE VESSEL WALL. ADDITIONALLY, IT IS POSSIBLE THAT THE DEVICE WAS TOO SMALL IN DIAMETER AND WAS NEVER ABLE TO FULLY OPPOSE THE VESSEL WALL. THE DEVICE WAS NOT REMOVED INTACT; IT WAS DEPLOYED IN THE MICROCATHETER AND WAS NOT RETURNED FOR ANALYSIS. THERE IS NO RECOLLECTION OF THE PIPELINE BEING STUCK IN THE CAPTURE COIL AT ANY POINT.
MEDTRONIC RECEIVED A REPORT THAT THE PATIENT WAS UNDERGOING TREATMENT FOR A SACCULAR, UNRUPTURED ICA SEGMENT ANEURYSM WITH A MAX DIAMETER OF 6.6 MM AND A 4MM NECK DIAMETER. IT WAS NOTED THAT THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. THE LANDING ZONE WAS 3.5MM DISTALLY AND 3.8MM PROXIMALLY. IT WAS REPORTED THAT A SERIES OF DEVICE-RELATED EVENTS WERE REPORTED DURING NEUROINTERVENTIONAL PROCEDURES. FOR ARTISSE ISF-080-050 (LOT: B806637), AFTER OPENING AND DEGASSING THE DEVICE INTO A SALINE BUCKET AND CONFIRMING THAT THE IMPLANT AND DELIVERY WIRE APPEARED INTACT, MULTIPLE UNSUCCESSFUL ATTEMPTS WERE MADE TO INTRODUCE THE DEVICE INTO THE MICROCATHETER HUB. UPON RETRIEVAL, THE DISTAL WIRE WAS FOUND TO BE SEVERELY KINKED, WHICH WAS ATTRIBUTED TO INCORRECT SEATING IN THE MICROCATHETER HUB DURING LOADING. THE DEVICE WAS NOT IMPLANTED AND HAS BEEN BAGGED FOR ANALYSIS AT THE PHYSICIAN'S REQUEST AS POTENTIALLY "DEFECTIVE OUT OF THE BOX." ANOTHER ARTISSE ISF-080-050 (LOT: B812940) WAS USED WITHOUT ISSUE. FOR PIPELINE SHIELD PED2-450-18 (LOT: D003161), ALTHOUGH THE DEVICE WAS SUCCESSFULLY INTRODUCED AND NAVIGATED, DISSATISFACTION WITH DISTAL OPENING LED TO RECAPTURE ATTEMPTS, CAUSING THE ACCESS SYSTEM TO FALL BACK, REQUIRING A WIRE AND RESULTING IN PREMATURE DEPLOYMENT WITHIN THE MICROCATHETER. MIGRATION OF THE PIPELINE OCCURRED AFTER DEPLOYMENT, WITH RESHEATHING IDENTIFIED AS THE CAUSE. THE PIPELINE WAS IMPLANTED AT THE INTENDED LOCATION; HOWEVER, FULL WALL APPOSITION WAS NOT ACHIEVED, AND BALLOONING WAS NOT REQUIRED FOR TAPERING OR TO ENSURE WALL APPOSITION. NO SIDE BRANCHES WERE COVERED BY THE PIPELINE. THE PIPELINE SHIELD PED2-450-16 (LOT: D003969) WAS DEPLOYED WITHOUT ISSUE, BUT THE PROXIMAL END WAS DEPLOYED ON A CURVE, LEADING TO DISTAL FORESHORTENING AND NECESSITATING AN ADDITIONAL STENT FOR DISTAL ANCHORING. LASTLY, FOR PIPELINE SHIELD PED2-400-10 (LOT: D006277), A SIMILAR ISSUE OCCURRED AS WITH THE PREVIOUS PIPELINE DEVICE¿AFTER LOSING ACCESS, THE PHYSICIAN WAS UNABLE TO RECANNULATE WHILE THE DEVICE REMAINED LOADED, AND IT WAS NOT IMPLANTED. FAILURE TO OPEN OCCURRED IN THE DISTAL SECTION OF THE PIPELINE, WHICH WAS POSITIONED IN A BEND. IT IS NOT SPECIFIED WHETHER THE PIPELINE WAS STUCK IN THE CAPTURE COIL. THE AMOUNT OF THE PIPELINE DEPLOYED AT THE TIME OF FAILURE, THE NUMBER OF RESHEATHING ATTEMPTS, AND WHETHER ANY ADDITIONAL STEPS OR DEVICES WERE USED TO OPEN THE PIPELINE ARE CURRENTLY UNKNOWN AND WILL. THE PIPELINE WAS REMOVED FROM THE PATIENT, BUT IT IS ALSO UNKNOWN IF IT WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS GOOD. IT WAS UNKNOWN IF THE PIPELINE WAS USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-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.
ADDITIONAL INFORMATION WAS RECEIVED. FOR THE ARTISSE ISF 080 050 (LOT B806637), THE CAUSE OF THE KINK AND MULTIPLE UNSUCCESSFUL ATTEMPTS WAS NOT DEFINITIVELY DETERMINED DURING THE PROCEDURE; HOWEVER, THE PHYSICIAN BELIEVED THE ISSUE MAY HAVE BEEN RELATED TO THE DEVICE NOT BEING CORRECTLY SEATED IN THE HUB OR THE BRAID NOT BEING PROPERLY SEATED IN THE SHEATH DURING INTRODUCTION, WHICH IS A COMMONLY ENCOUNTERED ISSUE. FOR THE PIPELINE SHIELD PED2 450 18 (LOT D003161), THE PHYSICIAN BELIEVED THE FAILURE TO OPEN DISTALLY, SYSTEM FALLBACK, MIGRATION DURING DEPLOYMENT, AND LACK OF FULL WALL APPOSITION WERE MOST LIKELY DUE TO INSUFFICIENT SUPPORT AND TORTUOUS PROXIMAL ANATOMY, ALTHOUGH A DISTAL DEVICE RELATED ISSUE COULD NOT BE RULED OUT; THE DEVICE WAS ULTIMATELY DEPLOYED WITHIN THE MICROCATHETER HUB DURING RETRIEVAL AND THEREFORE WAS NOT AVAILABLE FOR EVALUATION. FOR THE PIPELINE SHIELD PED2 450 16 (LOT D003969), DISTAL FORESHORTENING WAS BELIEVED TO HAVE OCCURRED DUE TO EXCESSIVE LOAD APPLIED TO THE PROXIMAL END DURING DEPLOYMENT, RESULTING IN DRAGGING OF THE DISTAL END, AND WAS ATTRIBUTED TO INCORRECT DEPLOYMENT TECHNIQUE. FOR THE PIPELINE SHIELD PED2 400 10 (LOT D006277), THE DEVICE WAS NOT DEPLOYED IN THE PATIENT BUT WAS ACCIDENTALLY DEPLOYED ONTO THE TABLE WITHIN THE MICROCATHETER HUB, AN EVENT ATTRIBUTED TO INCORRECT DEPLOYMENT TECHNIQUE. THE PEDS WON'T BE RETURNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231143 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-450-18 | D003161 | 00847536002548 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |