PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2026-00694
- Event Type
- Malfunction
- Date Received
- April 20, 2026
- Date of Event
- April 14, 2026
- Report Date
- April 21, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00847536002920
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO
- 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.
B5: UPDATE DUE TO A DUPLICATE FILE REPORTED IT WAS MERGED AND FURTHER CLARIFYING EVENT INFORMATION WAS PROVIDED. 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 PIPELINE STENT FAILED TO OPEN DISTALLY AND WAS FRAYED. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, RUPTURED LEFT OPHTHALMIC "ROTIDO" ANEURYSM WITH A MAX DIAMETER OF 4.5 MM AND A COLLARLESS NECK DIAMETER. THE LANDING ZONE WAS 4.4 MM DISTALLY AND 4.78 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED AT AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST PROCEDURE WAS NORMAL WITH CEREBRAL PERFUSION. IT WAS REPORTED THAT THE "DF IS PURGED." THE "DF" PIPELINE FLEX SHIELD (PED2-500-25) WAS RAISED THROUGH THE PHENOM 27 MICROCATHETER THROUGH AN INTERMEDIATE CATHETER PHENOM PLUS CATHETER. DEPLOYMENT BEGAN UNDER THE BIFURCATION OF THE ACM AND HERE, THE DIVERTER PUSHER WAS PUSHED AND IT WAS RELEASED UP TO THE MIDDLE OF THE DF BODY. IT WAS EVIDENT THAT THE DISTAL PART OF THE DF DID NOT OPEN THEREFORE THE RECAPTURE OF THE DEVICE BEGAN. ONCE RECAPTURED, THE DEPLOYMENT OF THE DEVICE STARTED AGAIN UNTIL THE INITIAL CURVE OF THE CAROTID WHERE IT WAS EVIDENT THAT THE DISTAL END CONTINUED TO BE UNOPENED. IN THE CURVE IF IT WAS OPENED, THE SPECIALIST RECAPTURED THE DEVICE SINCE THE DISTANT END CONTINUED TO BE UNOPENED, THIS PROCESS WAS PERFORMED SEVERAL TIMES. REPOSITIONING MICROCATHETER AND DF WITHOUT OBTAINING AN OPENING OF THE DISTAL PART OF THE DF INSIDE THE VESSEL, THE SPECIALIST PROCEEDED TO REMOVE THE SYSTEM AND DECIDED TO VERIFY IT ON THE TABLE WHERE IT WAS EVIDENT THAT IT DID NOT OPEN THE DISTAL END "Y" AND THAT THE DISTAL PART OF THE DF, THAT IS IMMEDIATELY AFTER THE WINGS, HAD FRAYED DF FIBERS. THEREFORE THE SPECIALIST PROCEEDED TO CHANGE IT. THE PIPELINE WAS NOT USED FOR AN INDICATION THAT IS NOT APPROVED (OFF-LABEL). THE PIPELINE AND ACCESSORY DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS STUCK IN THE CAPTURE OIL. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES USED TO RELEASE THE PIPELINE FROM THE CAPTURE COIL. ADDITIONALLY, "NO JAMMED REPORT DOES NOT ALLOW MODIFICATION TO NO JAM ON COIL." THE PIPELINE WAS RELEASED FROM THE CAPTURE COIL. THE PHYSICIAN DID NOT "TURN IT AROUND", THE PHYSICIAN JUST PUSHED. MORE THAN 50% OF THE PIPELINE HAD BEEN DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN 2 TIMES. THERE WERE ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE. A PUSHING TECHNIQUE AND GIVING TENSION TO THE SYSTEM WAS DONE BUT IT DID NOT WORK. THE PIPELINE WAS RESHEATHED AND REMOVED WITH THE MICROCATHETER, AND FROM THE PATIENT. THE DF NEVER OPENED IN THE DISTAL PART AND IT DID FRAY. ADDITIONALLY, THE DF WAS CHANGED FOR A PED2-500-20 WHICH DID NOT WORK EITHER. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. THERE WAS NO MEDICAL OR SURGICAL INTERVENTION NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION. THE EVENT DID NOT LEAD TO OR EXTENT PATIENT HOSPITALIZATION. THERE WAS NO INJURY AS A RESULT OF THE EVENT. ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER (FG15150-0615-1S, LOT: 230602991) AND A PHENOM PLUS INTERMEDIATE CATHETER.
MEDTRONIC RECEIVED A REPORT OF 2 FLOW DIVERTERS THAT FAILED TO OPEN IN THE DISTAL POTION OF THE DEVICE. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A FUSIFORM, UNRUPTURED ANEURYSM WITH A MAX DIAMETER OF 4.5MM AND A "COLLARLESS" NECK DIAMETER. THE LANDING ZONE (ARTERY SIZE) WAS 4.4MM DISTAL AND 4.78MM PROXIMAL. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS SEVERE. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED WITH AN UNKNOWN PLATELET REACTIVITY UNITS (PRU) LEVEL. THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS, ¿PERFUSION CEREBRAL NORMAL.¿ IMAGES ARE AVAILABLE FOR REVIEW. IT WAS REPORTED THAT A NEW SYSTEM FOR THE TREATMENT OF AN OPERATION IS CARRIED OUT FOR THE SAME SURGICAL TIME. THROUGH THE PHENOM PLUS, A PHENOM 27 MICROCATHETER IS INSERTED WITH A PIPELINE FLEX 5X20, WHICH ONCE LOCATED, THE BIFURCATION OF THE ANEURYSM OF THE MIDDLE CEREBRAL ARTERY (ACM) IS DEPLOYED AND HERE IN THE STRAIGHT SEGMENT. IT IS ADVANCED ONCE AGAIN THAT THE PIPELINE (FLOW DIVERTER) DOES NOT OPEN IN ITS DISTAL PORTION. WITH A RELEASE PATH FOR MORE THAN 50% IMMEDIATELY PROCEED TO RECAPTURE AND REPOSITION THE SYSTEM. THE DOCTOR MAKES A SECOND ATTEMPT AT DEPLOYMENT, BUT THE PIPELINE (FLOW DIVERT) CONTINUES TO REMAIN CLOSED. THE DOCTOR APPLIES PUSH AND RECAPTURE MANEUVERS SEVERAL TIMES, BUT THE DEVICE DOES NOT REACT, THEREFORE IT IS EXTRACTED WITH A MICROCATHETER. THE PROCEDURE IS COMPLETED WITH THE DOCTOR HAVING REQUESTED A DEVICE WITH ANOTHER COMMERCIAL HOUSE WHICH IS SUCCESSFULLY IMPLANTED IN THE PATIENT. IT WAS NOTED THAT THE PIPELINE WAS NOT POSITIONED IN A BEND. THE PIPELINE WAS NOT STUCK IN THE CAPTURE COIL. MORE THAN 50% OF THE DEVICE WERE DEPLOYED WHEN IT FAILED TO OPEN. THE PIPELINE WAS RESHEATHED MORE THAN TWO TIMES. THERE WERE NO OTHER ADDITIONAL STEPS OR OTHER DEVICES REQUIRED TO OPEN THE PIPELINE THAT WAS NOT MENTIONED. ADDITIONAL DETAILS PROVIDED THAT TWO FLOW DIVERTERS WERE USED IN THE SAME PROCEDURE WITHOUT ACHIEVING DISTAL APPOSITION OF THE SAME STRAIGHT SEGMENT OF THE CAROTID. ¿SIMILAR BEHAVIORS IN THE 2 DEVICES.¿ NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT OF FUNCTION. THIS EVENT DID NOT LEAD TO OR EXTEND THE PATIENTS HOSPITALIZATION. THE PIPELINE WAS NOT USED FOR ANY INDICATION THAT IS NOT APPROVED (OFF-LABEL). IT WAS INDICATED THAT ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU), AND NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. ANCILLARY DEVICES INCLUDE A PHENOM 27 MICROCATHETER REF FG15150-0615-1S LOT 232476590.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 586383 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-500-25 | D023094 | 00847536002920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |