PIPELINE VANTAGE WITH SHIELD TECHNOLOGY
Report
- Report Number
- 2029214-2025-01101
- Event Type
- Malfunction
- Date Received
- April 30, 2025
- Date of Event
- April 23, 2025
- Report Date
- September 15, 2025
- Manufacturer
- MICRO THERAPEUTICS, INC. DBA EV3
- Product Code
- OUT
- UDI-DI
- 00847536030688
- PMA / PMN Number
- P100018
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PL
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
CONTINUATION OF D10: PRODUCT ID 103-0606-200 (LOT: D007586); PRODUCT TYPE: PRODUCT ID FG13150-0615-2S (LOT: 225744070); 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.
H3. PRODUCT ANALYSIS: EQUIPMENT USED: VIDEO INSPECTION SYSTEM (M-81805), RULER (M-83361), CAMERA (PANASONIC LUMIX DMC-ZS5) AS FOUND CONDITION: THE PIPELINE VANTAGE DEVICE WAS RETURNED PARTIALLY DEPLOYED AND STUCK INSIDE A PHENOM 21 CATHETER, LOCATED WITHIN AN OPENED PIPELINE VANTAGE INNER POUCH, WHICH WAS INSIDE A SEALED BIOHAZARD BAG, AND WITHIN A SHIPPING BOX. DAMAGED LOCATION DETAILS: THE PIPELINE VANTAGE TIP COIL WAS IN GOOD CONDITION. THE DISTAL AND PROXIMAL DPS RESTRAINTS AND DPS SLEEVES WERE INTACT, WITH NO SIGNS OF DAMAGE. NO DEFECTS WERE FOUND ON THE RE-SHEATHING MARKER OR WITH THE PROXIMAL BUMPER. THE DISTAL HYPOTUBE WAS FOUND TO BE STRETCHED. THE BRAID¿S DISTAL END WAS OPENED AND FRAYED, WHILE THE PROXIMAL END WAS FOUND TAPERED AND CLOSED WITH DRIED BLOOD. THE PHENOM 21 CATHETER TIP AND MARKER WERE EXAMINED, AND NO DAMAGE WAS NOTED. THE CATHETER BODY WAS FOUND TO BE ACCORDIONED AT MULTIPLE LOCATIONS, ~1.0CM TO ~3.0CM AND ~9.5CM TO ~13.0CM FROM THE DISTAL TIP. ALSO, AT ~4.5CM TO ~12.5CM FROM THE PROXIMAL END OF THE CATHETER HUB. NO FLASHES OR VOIDS WERE FOUND IN THE CATHETER HUB. NO OTHER ANOMALIES WERE FOUND. TESTING/ANALYSIS: THE PIPELINE VANTAGE WAS PUSHED OUT FROM THE PHENOM 21 CATHETER LUMEN WITH DIFFICULTY. THE CATHETER'S TOTAL AND USABLE LENGTH WERE MEASURED AND WERE WITHIN SPECIFICATIONS. THE CATHETER WAS FLUSHED WITH WATER AND FOUND PATENT. THE CATHETER WAS TESTED BY RUNNING AN IN-HOUSE 0.21¿ MANDREL THROUGH THE CATHETER HUB WITHOUT ISSUES; HOWEVER, RESISTANCE WAS OBSERVED AT THE DAMAGED LOCATIONS. CONCLUSION: BASED ON THE REPORTED INFORMATION AND DEVICE ANALYSIS, THE CUSTOMER¿S ¿RESISTANCE¿ COMPLAINTS WERE CONFIRMED, AS THE RETURNED PIPELINE VANTAGE DEVICE AND THE PHENOM 21 CATHETER WERE FOUND TO BE DAMAGED. THE DAMAGE NOTED ON THE BRAID (FRAYING) AND CATHETER (ACCORDIONING) INDICATES THAT HIGH FORCE WAS USED. THE DAMAGE MAY HAVE OCCURRED WHEN THE USER ATTEMPTED TO ADVANCE/RETRIEVE THE PIPELINE VANTAGE DEVICE THROUGH THE PHENOM 21 CATHETER AGAINST RESISTANCE. HOWEVER, THE CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. POSSIBLE CAUSES OF RESISTANCE INCLUDE SEVERE VESSEL TORTUOSITY, AN INCOMPATIBLE/DAMAGED CATHETER, BRAID DAMAGE, AND A LACK OF CONTINUOUS FLUSH WITH SALINE/HEPARINIZED SALINE DURING THE PROCEDURE. IN THIS EVENT, THE REPORTED PHENOM 21 CATHETER WAS COMPATIBLE WITH THE PIPELINE VANTAGE DEVICE AS IT HAS A LABELED INNER DIAMETER (ID) OF 0.021 INCHES, AND THE CUSTOMER STATED THAT A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED, RULING OUT AN INCOMPATIBLE CATHETER AND A LACK OF CONTINUOUS FLUSH WITH SALINE/HEPARINIZED SALINE DURING THE PROCEDURE AS POTENTIAL CAUSES. THEREFORE, SEVERE VESSEL TORTUOSITY, DAMAGED CATHETER, OR BRAID DAMAGE COULD HAVE CONTRIBUTED TO THE RESISTANCE COMPLAINT. THE BRAID CAN BE DAMAGED DUE TO OVER-MANIPULATION, RE-SHEATHING MORE THAN TWICE, IMPROPER DEPLOYMENT TECHNIQUE, DELIVERING/RETRACTING THE DELIVERY WIRE AGAINST RESISTANCE, OR DEPLOYING/RE-SHEATHING AGAINST RESISTANCE. THE CUSTOMER¿S REPORT OF "MOVEMENT DURING DEPLOYMENT" COULD NOT BE CONFIRMED DURING DEVICE ANALYSIS. HOWEVER, THE CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. POSSIBLE CAUSES INCLUDE VASOSPASM, SEVERE VESSEL TORTUOSITY, AND A HIGH-FORCE DELIVERY. PER THE INSTRUCTIONS FOR USE (IFU): ¿USE IN ANATOMY WITH SEVERE TORTUOSITY, STENOSIS, OR PARENT VESSEL NARROWING MAY RESULT IN DIFFICULTY OR INABILITY TO DEPLOY THE PIPELINE VANTAGE DEVICE AND CAN LEAD TO DAMAGE TO THE PIPELINE VANTAGE DEVICE AND MICROCATHETER.¿ H6. CODING UPDATED BASED ON ANALYSIS FINDINGS. 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.
IT WAS REPORTED THAT DURING A NEUROVASCULAR FLOW DIVERSION PROCEDURE USING THE PIPELINE VANTAGE WITH SHIELD TECHNOLOGY, THERE WERE SEVERAL ISSUES ENCOUNTERED. THE PROCEDURE INVOLVED AN UNRUPTURED ANEURYSM LOCATED AT THE M2 SEGMENT. SEVERE VESSEL TORTUOSITY WAS NOTED, WHICH CONTRIBUTED TO MOVEMENT AND DIFFICULTY DURING THE PLACEMENT AND POSITIONING OF THE DEVICE. THERE WAS FRICTION DURING DELIVERY, AND THE DEVICE WAS OPENED BUT SLID DOWN, PROMPTING THE DOCTOR TO ATTEMPT CLOSING AND REOPENING IT, THOUGH THE FLOW DIVERTER DID NOT REACT. DUAL ANTIPLATELET TREATMENT WITH ASA AND CLOPIDOGREL WAS ADMINISTERED, AND THE ANGIOGRAPHIC RESULT POST-PROCEDURE WAS REPORTED AS GOOD. THE PATIENT WAS ALIVE WITH NO INJURY. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
ADDITIONAL INFORMATION RECEIVED REPORTED THAT IT WAS UNKNOWN HOW THE PATIENT WAS RECOVERING FROM THE PROCEDURE. IT WAS NOTED THAT THE CAUSE OF THE PIPELINE FAILURE MAY HAVE BEEN DUE TO VERY HARD SINUOSITY ARTERIES. IT WAS UNKNOWN IF THE DEVICE JUMPED OR THE CATHETER TIP MOVED DURING DEPLOYMENT. IT WAS UNKNOWN AS TO WHICH SECTIONS OF THE PIPELINE DID NOT OPEN. A CONTINUOUS SALINE FLUSH WAS ADMINISTERED AND MAINTAINED AS INDICATED IN THE IFU. THERE WAS NO DAMAGE FOUND TO THE CATHETER HUB. THERE WAS NO KINK DAMAGED FOUND ON THE GUIDEWIRE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2413954 | PIPELINE VANTAGE WITH SHIELD TECHNOLOGY | INTRACRANIAL ANEURYSM FLOW DIVERTER | OUT | MICRO THERAPEUTICS, INC. DBA EV3 | PED3-021-350-12 | B643509 | 00847536030688 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 79 YR | Female | SEE H11... |