BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHENOM CATHETER

    MDR report key: 24190423 · Received January 27, 2026

    Report

    Report Number
    9617601-2026-00665
    Event Type
    Malfunction
    Date Received
    January 27, 2026
    Date of Event
    January 22, 2026
    Report Date
    March 2, 2026
    Manufacturer
    MEDTRONIC MEXICO S. DE R.L. DE CV
    Product Code
    QJP
    UDI-DI
    00763000304294
    PMA / PMN Number
    K151638
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONTINUATION OF D10: PIPELINE VANTAGE WITH SHIELD TECHNOLOGY STENT PRODUCT ID PED3-021-350-14 (LOT B815913);  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 Manufacturer Narrative · 0

    UPDATE B5 AND H6. 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.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A REPORT THAT WHEN LESS THAN 1/3 OF THE TOTAL PIPELINE VANTAGE WITH SHIELD TECHNOLOGY STENT (PED3) BEGAN TO BE DE PLOYED TO LEAVE IT ON THE CAROTID TIP, THE SYSTEM FELL OUT, LEAVING PART OF THE ANEURYSMAL NECK UNCOVERED. AN ATTEMPT WAS MADE TO RECAPTURE/RE-SHEATH THE STENT TO REPOSITION IT AGAIN, HOWEVER, THE STENT ENCOUNTERED RESISTANCE, DID NOT ENTER THE DISTAL PHENOM 21 MI CROCATHETER, AND COULD NOT BE RESHEATHED. AN ATTEMPT WAS MADE TO REMOVE TENSION OUT OF THE SYSTEM BUT IT DID NOT RESOLVE THE ISSUE. THE MICROCATHETER WAS REMOVED WITH THE STENT STUCK AND PARTIALLY DEPLOYED AS IT COULD NOT BE RE-SHEATHED. THE PRODUCTS WERE REPLACED WITH MEDTRONIC PRODUCTS TO COMPLETE THE PROCEDURE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT. MEDICAL OR SURGICAL INTERVENTION WAS NOT NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT POSTERIOR COMMUNICATING ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3 MM DISTALLY AND 3.5 MM PROXIMALLY. IT WAS NOTED THE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. RADIAL DER ACCESS VESSEL DIAMETER WAS 4 MM. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED ANGIOGRAPHY WITHOUT SIGNIFICANT LESIONS. THE PATIENT HAS A HISTORY OF HYPOTHYROIDISM, SUBARACHNOID HEMORRHAGE DUE TO RUPTURE OF AN. LEFT POSTERIOR COMMUNICATOR PREVIOUSLY TREATED WITH COILS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THERE WAS NO DAMAGE TO THE CATHETER OR PUSHWIRE. IT WAS REPORTED THAT THERE WAS NO ALLEGED ISSUE WITH THE MICROCATHETER. ANCILLARY DEVICES INCLUDED 6F SHUTTLE SHEATH.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. ONLY ONE PIPELINE DEVICE WAS USED DURING THE EVENT. THERE WAS DIFFICULTY DURING DELIVERY AND POSITIONING, AS AN ATTEMPT TO RECAPTURE AND RESHEATH THE DEVICE FOR REPOSITIONING WAS NOT POSSIBLE. DURING DEPLOYMENT, WHEN LESS THAN ONE THIRD OF THE FLOW DIVERTER HAD BEEN RELEASED IN AN ATTEMPT TO REPOSITION IT OVER THE CAROTID TIP, A SYSTEM DROP WAS OBSERVED, RESULTING IN PART OF THE ANEURYSMAL NECK REMAINING UNCOVERED. MOVEMENT OF THE CATHETER TIP WAS NOTED DURING DEPLOYMENT. THE PATIENT WAS UNDERGOING DENSE MESH FLOW DIVERSION SURGERY FOR TREATMENT OF AN UNRUPTURED, SACCULAR, LEFT POSTERIOR COMMUNICATING ANEURYSM WITH A MAX DIAMETER OF 3 MM AND A 2 MM NECK DIAMETER. THE LANDING ZONE ARTERIAL DIAMETER WAS 3 MM DISTALLY AND 3.5 MM PROXIMALLY. IT WAS NOTEDTHE PATIENT'S VESSEL TORTUOSITY WAS MODERATE. RADIAL DER ACCESS VESSEL DIAMETER WAS 4 MM. THE ANGIOGRAPHIC RESULT POST PROCEDURE REPORTED ANGIOGRAPHY WITHOUT SIGNIFICANT LESIONS. THE PATIENT HAS A HISTORY OF HYPOTHYROIDISM, SUBARACHNOID HEMORRHAGE DUE TO RUPTURE OF AN. LEFT POSTERIOR COMMUNICATOR PREVIOUSLY TREATED WITH COILS. THE REPORTED DEVICE AND ANY ACCESSORY DEVICES WERE PREPARED, AND THE CATHETER WAS FLUSHED, AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THE PIPELINE WAS USED FOR AN APPROVED INDICATION (ON-LABEL). THE CATHETER WAS FLUSHED CONTINUOUSLY WITH HEPARINIZED SALINE. THERE WAS NO DAMAGE TO THE CATHETER OR PUSHWIRE. IT WAS REPORTED THAT THERE WAS NO ALLEGED ISSUE WITH THE MICROCATHETER. ANCILLARY DEVICES INCLUDED 6F SHUTTLE SHEATH. 2026-FEB-05 E1 (HCP, REP, FOR): ADDITIONAL INFORMATION WAS RECEIVED. THE CAUSE OF THE RESISTANCE COULD NOT BE DETERMINED. ONLY ONE PIPELINE DEVICE WAS USED DURING THE EVENT. THERE WAS DIFFICULTY DURING DELIVERY AND POSITIONING, AS AN ATTEMPT TO RECAPTURE AND RESHEATH THE DEVICE FOR REPOSITIONING WAS NOT POSSIBLE. DURING DEPLOYMENT, WHEN LESS THAN ONE THIRD OF THE FLOW DIVERTER HAD BEEN RELEASED IN AN ATTEMPT TO REPOSITION IT OVER THE CAROTID TIP, A SYSTEM DROP WAS OBSERVED, RESULTING IN PART OF THE ANEURYSMAL NECK REMAINING UNCOVERED. MOVEMENT OF THE CATHETER TIP WAS NOTED DURING DEPLOYMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    253582 PHENOM CATHETER CATHETER, PERCUTANEOUS, NEUROVASCULATURE QJP MEDTRONIC MEXICO S. DE R.L. DE CV FG13150-0615-2S 228323967 00763000304294

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male SEE H11...