PIPELINE FLEX W/SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2025-02281
- Event Type
- Malfunction
- Date Received
- October 27, 2025
- Date of Event
- October 24, 2025
- Report Date
- January 12, 2026
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00847536002630
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
B5. UPDATED WITH ADDITIONAL INFORMATION RECEIVED. 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: PED2-500-14 (D022996); IMPLANT DATE; EXPLANT DATE: PRODUCT ID: FG15150-0615-1S (231339802); 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: PRODUCT ANALYSIS OF PED2-500-12, LOT NO: D035486 ¿ AS FOUND CONDITION: THE PIPELINE FLEX SHIELD WAS RETURNED INSIDE THE INNER POUCH, WITHIN A BIO-HAZARD BAG AND A SHIPPING BOX. ¿ DAMAGE LOCATION DETAILS: THE DISTAL AND PROXIMAL DPS RESTRAINTS WERE INTACT. THE DPS SLEEVES SHOWED NO SIGNS OF DAMAGE AND WERE FOUND TO BE INTACT. THE DISTAL HYPOTUBE APPEARED TO BE STRETCHED, BUT THE PTFE SHRINK TUBING REMAINED INTACT. THE DISTAL END OF THE BRAID WAS NOT OPEN AND FRAYED. THE PROXIMAL END OF THE BRAID WAS FOUND TO BE OPEN AND FRAYED. NO DEFECTS WERE FOUND IN THE TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, RESHEATHING PAD, OR PROXIMAL BUMPER. NO OTHER ANOMALIES WERE OBSERVED. ¿ CONCLUSION: BASED ON THE RETURNED DEVICES, THE CUSTOMER REPORT OF "FAILURE TO OPEN AT THE DISTAL END" WAS CONFIRMED, AS THE BRAID'S DISTAL END WAS NOT OPEN AND FRAYED. THE CAUSE OF THE FAILURE TO OPEN COULD NOT BE DETERMINED. POSSIBLE CAUSES FOR THIS FAILURE INCLUDE VESSEL TORTUOSITY, A DAMAGED BRAID, OR DEPLOYMENT OF THE BRAID IN A VESSEL BEND. THE CUSTOMER REPORTED THAT THE VESSEL TORTUOSITY WAS MODERATE, RULING IT OUT AS A POTENTIAL CAUSE. IT IS POSSIBLE THAT THE DAMAGE TO THE BRAID AND ITS DEPLOYMENT IN THE VESSEL BEND MAY HAVE CONTRIBUTED TO THE FAILURE TO OPEN. SUCH DAMAGE CAN OCCUR DUE TO RESHEATHING MORE THAN TWICE, OVER-MANIPULATION, IMPROPER DEPLOYMENT TECHNIQUE, OR RESISTANCE ENCOUNTERED WHEN ADVANCING OR RETRACTING THE DELIVERY WIRE, AS WELL AS DURING DEPLOYMENT OR RE-SHEATHING AGAINST RESISTANCE. 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 UPDATED WITH ADDITIONAL INFORMATION RECEIVED. 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 REPORTED THE EVENT WAS POSSIBLY CAUSED BY PATIENT'S VESSEL TORTUOSITY.
MEDTRONIC RECEIVED INFORMATION REGARDING TWO PIPELINE FLEX WITH SHIELD STENTS THAT FAILED TO OPEN AT THE DISTAL ENDS, ONE OF WHICH HAD RESISTANCE DURING RETRIEVAL IN A PHENOM 27 MICROCATHETER. THE PATIENT WAS UNDERGOING A PROCEDURE TO TREAT A LEFT PARAOPHTHALMIC UNRUPTURED SACCULAR ANEURYSM. THE ANEURYSM MAX DIAMETER WAS 55MM AND THE NECK WAS 3MM. PATIENT'S VESSEL TORTUOSITY WAS MODERATE. DUAL ANTIPLATELET TREATMENT (DAPT) WAS ADMINISTERED. IT WAS REPORTED THAT THE DEVICES WERE PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE CATHETER DELIVERY SYSTEM WAS NAVIGATED IN PLACE AND THE PIPELINE (PED2-500-14, LOT: D022996) WAS DELIVERED. THE SYSTEM WAS DRAWN BACK SLIGHTLY TO THE M1 SEGMENT AND UNSHEATHING INITIATED. WHEN LESS THAN 50% OF THE PIPELINE WAS DEPLOYED, IT OPENED SLIGHTLY, BUT NOT FULLY, IN THE STRAIGHT SEGMENT. THE CLINICIAN RESHEATHED OVER THE PTFE SLEEVE AND DEPLOYED AGAIN BUT THE PIPELINE STILL DID NOT OPEN FULLY. THE PIPELINE BRAID WAS RESHEATHED AGAIN, THEN EXPOSED APPROXIMATELY HALFWAY AND THE DEVICE WAS DRAWN BACK TO THE INTERNAL CAROTID ARTERY (ICA) AND THE CLINICIAN OPEN MORE THE PIPELINE PAST THE ANEURYSM NECK AND PERFORMED A LOT OF MANIPULATIONS, SUCH AS WAGGING, TO OPEN THE DEVICE WITHOUT SUCCESS. THE PIPELINE OPENED AT THE BEND OF THE PARAOPHTHALMIC SEGMENT AND THE PROXIMAL SEGMENT WAS OPENING, HOWEVER, THE DISTAL END STILL DID NOT OPEN COMPLETELY AND APPEARED TO POSSIBLY BE TWISTED OR BENT IN THE VESSEL. IT WAS NOTED THAT THE MIDDLE SEGMENT OF THE PIPELINE WAS POSITIONED IN A BEND. AFTER SEVERAL ATTEMPTS AND RESHEATHING TO DEPLOY MORE DISTAL AND OPEN HIGHER IN THE ICA, THE CLINICIAN DECIDED TO REMOVE AND REPLACE THE DEVICE. THE PIPELINE WAS VERY DIFFICULT TO RETRIEVE BACK IN THE PHENOM 27 MICROCATHETER SO WHEN THE SYSTEM WAS REMOVED, THE CLINICIAN USED A SCALPEL TO CUT THE MICROCATHETER OPEN TO CONFIRM ALL PIECES OF THE PIPELINE HAD, IN FACT, BEEN SUCCESSFULLY REMOVED. A SHORTER PIPELINE (PED2-500-12, LOT: D035486) WAS THEN TRIED. A NEW PHENOM 27 MICROCATHETER WAS NAVIGATED TO THE M2 SEGMENT AND THE PIPELINE TIP WAS DRAWN BACK TO THE M1 WHERE THE BRAID WAS UNSHEATHED. THIS DEVICE APPEARED TO OPEN SLIGHTLY BETTER THAN THE FIRST BUT STILL NOT FULLY OPEN AT THE DISTAL THIRD THOUGH THE REST OF THE DEVICE WAS OPENING AROUND THE GENU OF THE ANEURYSM NECK WITH SOME MANIPULATION. LESS THAN 50% OF THE DEVICE WAS DEPLOYED WHEN IT FAILED TO OPEN. THE MIDDLE SEGMENT WAS POSITIONED IN A BEND. THE DEVICE WAS RESHEATHED MORE THAN 2 TIMES. THERE WERE NO OTHER STEPS OR DEVICES USED TO OPEN THE PIPELINE WHICH WAS RESHEATHED AND REMOVED WITH THE PHENOM MICROCATHETER AND BOTH DEVICES WERE AGAIN REPLACED. A THIRD PHENOM 27 MICROCATHETER WAS THEN USED TO DELIVER A NON-MEDTRONIC STENT WHICH FIRST APPEARED TO HAVE THE SAME PROBLEM OPENING AS THE PIPELINES BUT OPENED BETTER WHEN IT WAS DRAWN BACK TO THE POSITION IN THE ICA. ANGIOPLASTY WAS THEN REQUIRED TO FULLY OPEN THE NON-MEDTRONIC STENT AND COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO HARM OR INJURY TO THE PATIENT ASSOCIATED WITH THIS EVENT. ANCILLARY DEVICES: BENCHMARK 071 95CM GUIDE CATHETER, PHENOM 27 MICROCATHETERS (LOT: 231339802, LOT: 229306874), ECHELON MICROCATHETER, STRYKER 360 SOFT 4X8 COIL(S).
ADDITIONAL INFORMATION RECEIVED REPORTED THERE WAS NO DAMAGE TO THE PHENOM 27 MICROCATHETER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2307424 | PIPELINE FLEX W/SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED2-500-12 | D035486 | 00847536002630 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR | Female | SEE H11. |