PIPELINE FLEX
Report
- Report Number
- 2029214-2024-01915
- Event Type
- Malfunction
- Date Received
- October 17, 2024
- Date of Event
- October 15, 2024
- Report Date
- January 14, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- 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.
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 EMBOLIZATION DEVICE WAS RETURNED FOR ANALYSIS WITHIN SHIPPING BOX; AND WITHIN A PLASTIC BIO-POUCH. ¿ DAMAGE LOCATION DETAILS: NO BENT OR KINK WAS FOUND WITH PUSHWIRE. THE DISTAL HYPOTUBE WAS FOUND TO BE STRETCHED. THE SHRINK TUBING WAS FOUND INTACT BUT PULLED BACK FROM THE PROXIMAL BUMPER. 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 TIP COIL, DISTAL MARKER, RE-SHEATHING MARKER, PADS OR WITH THE PROXIMAL BUMPER. THE BRAID WAS RETURNED ALREADY DETACHED FROM THE PUSHER; THEREFORE, THE PROXIMAL AND DISTAL ENDS COULD NOT BE IDENTIFIED. THE PIPELINE FLEX BRAID ENDS WERE FOUND TO BE FULLY OPENED AND DAMAGED. IN ADDITION, THE MIDDLE SECTION OF THE BRAID WAS FOUND TO BE NOT FULLY OPENED AND TWISTED DUE TO DAMAGE BRAID. NO OTHER ANOMALIES WERE OBSERVED. ¿ TESTING/ANALYSIS: N/A ¿ CONCLUSION: BASED ON THE ANALYSIS FINDINGS, THE PIPELINE FLEX WAS CONFIRMED TO HAVE FAILURE TO OPEN AT THE MIDDLE SECTION AS THE MIDDLE SECTION OF PIPELINE FLEX BRAID WAS FOUND TO BE NOT FULLY OPENED DUE TO DAMAGED BRAID. HOWEVER4, THE ROOT CAUSE FOR DAMAGE COULD NOT BE DETERMINED. 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 DURING THE DEPLOYMENT PROCESS, THE PIPELINE WAS DEPLOYED MULTIPLE TIMES IN THE BODY, BUT THE MIDDLE SECTION COULD NOT BE OPENED. NO PATIENT SYMPTOMS OR FURTHER COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. THE PIPELINE WAS USED FOR AN APPROVED (ON-LABEL) INDICATION. THE DEVICE AND ANY ACCESSORIES WERE PREPARED AS INDICATED IN THE IFU. THE PATIENT WAS UNDERGOING SURGERY FOR TREATMENT OF A SACCULAR, UNRUPTURED RIGHT OPHTHALMIC ARTERY ANEURYSM WITH A MAX DIAMETER OF 9.8MM AND A 6.2MM NECK DIAMETER. THE LANDING ZONE WAS 3.89MM DISTALLY AND 4.67 PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS NORMAL. DUAL ANTIPLATELET THERAPY (DAPT) WAS ADMINISTERED, PLATELET REACTIVITY UNITS (PRU) LEVEL WAS CONVENTIONAL DUAL-ANTIBODY 7 DAYS. ANGIOGRAPHIC RESULT POST PROCEDURE WAS SLOWING BLOOD FLOW. ANCILLARY DEVICES INCLUDE A COOK6 SHEATH, 5F NAVIEN GUIDE CATHETER, PHENOM 27 MICROCATHETER, AND SYNCHRO2 GUIDEWIRE.
ADDITIONAL INFORMATION WAS RECEIVED THAT THE PIPELINE WAS NOT PLACED IN A VESSEL BEND WHEN IT FAILED TO OPEN. THERE WERE NO ADDITIONAL STEPS OR OTHER DEVICES ATTEMPTED TO OPEN THE PIPELINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1368291 | PIPELINE FLEX | LASER THERAPY PRODUCT | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED-425-20 | B671899 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Female |