BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RANGER PACLITAXEL-COATED PTA BALLOON CATHETER

    MDR report key: 18545080 · Received January 19, 2024

    Report

    Report Number
    2124215-2023-74204
    Event Type
    Injury
    Date Received
    January 19, 2024
    Date of Event
    May 17, 2023
    Report Date
    May 3, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    ONU
    UDI-DI
    08714729976189
    PMA / PMN Number
    P190019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER: (B)(6).

    Additional Manufacturer Narrative · 0

    A1 - PATIENT IDENTIFIER: (B)(6).

    Description of Event or Problem · 0

    ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT MID SUPERFICIAL FEMORAL ARTERY WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 150 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED BY USING 4.0 MM X 120 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED BY USING 5.0 MM X 100 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 6.0 MM X 150 MM RANGER DRUG-COATED BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON (B)(6) 2023, SUBJECT WAS NOTED WITH WORSENING SYMPTOMS RELATED TO PERIPHERAL ARTERY DISEASE IN THE RIGHT LEG. ON (B)(6) 2023, 120 DAYS POST INDEX PROCEDURE, 70% STENOSIS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY AND RIGHT MID SUPERFICIAL FEMORAL ARTERY WERE TREATED BY ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE OUTCOME OF THE EVENT IS UNKNOWN. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE PATIENT VISITED THE HOSPITAL WITH THE COMPLAINTS OF NEW ONSET OF PAIN AND NUMBNESS IN THE LOWER EXTREMITIES AND WAS ADVISED TO HAVE A RIGHT LEG ANGIOGRAM ON LATER DATE. ON (B)(6) 2023, SUBJECT VISITED THE HOSPITAL FOR SCHEDULED RIGHT LOWER EXTREMITY ANGIOGRAM WITH POSSIBLE INTERVENTION. ON THE SAME DAY, DUPLEX ULTRASONOGRAPHY PERFORMED REVEALED PRESENCE OF OCCLUSIVE DISEASE WITH HEAVY CALCIFICATION IN BILATERAL FEMORAL-POPLITEAL ARTERY AND TIBIAL VESSELS. SUBSEQUENTLY, RIGHT LOWER EXTREMITY ANGIOGRAPHY WAS PERFORMED WHICH REVEALED: PATENT AORTOILIAC SEGMENT, COMMON FEMORAL ARTERY, PROFUNDA FEMORIS ARTERY, MORE THAN 65 TO 70% OF STENOSIS IN THE PROXIMAL AND MID PORTIONS OF THE SUPERFICIAL FEMORAL ARTERY WHICH WAS CLOSER TO 75% ON THE IVUS, CALCIFIC HOWEVER PATENT POPLITEAL ARTERY WITH LESS THAN 10% STENOSIS, SEVERELY CALCIFIED ANTERIOR TIBIAL ARTERY, SEVERELY DISEASED TIBIAL PERONEAL TRUNK WITH UP TO 95% STENOSIS, DISTALLY OCCLUDED POSTERIOR TIBIAL ARTERY 75% STENOSIS AT PROXIMAL SEGMENT OF PERONEAL ARTERY. ON (B)(6) 2023, 120 DAYS POST INDEX PROCEDURE, 70% STENOSIS NOTED IN THE RIGHT SUPERFICIAL FEMORAL ARTERY WERE TREATED BY ORBITAL ATHERECTOMY FOLLOWED BY BALLOON ANGIOPLASTY USING 6 MM X 240 MM NON-BSC BALLOON. IN ADDITION, DURING THE REVASCULARIZATION PROCEDURE, 95% STENOSIS NOTED IN RIGHT TIBIO-PERONEAL TRUNK AND 75% STENOSIS NOTED IN RIGHT PERONEAL ARTERY WERE TREATED BY ORBITAL ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY USING 3 MM BALLOON AND 4 MM BALLOON. THE SUBJECT TOLERATED THE PROCEDURE WELL AND THERE WERE NO IMMEDIATE POST-PROCEDURE COMPLICATIONS. THE OUTCOME OF THE EVENT IS UNKNOWN. ON (B)(6) 2023, RIGHT LEG ARTERIAL DUPLEX WAS PERFORMED WHICH REVEALED MULTIPHASIC ARTERIAL WAVEFORMS WERE DETECTED IN THE RIGHT COMMON FEMORAL ARTERY, DEEP FEMORAL ARTERY, SUPERFICIAL FEMORAL ARTERY, AND POPLITEAL ARTERIES. MONOPHASIC WAVEFORMS ARE SEEN IN THE PERONEAL, ANTERIOR TIBIAL, AND DORSALIS PEDIS ARTERIES WITH OCCLUSION OF POSTERIOR TIBIAL ARTERY.

    Description of Event or Problem · 0

    ELEGANCE CLINICAL TRIAL. IT WAS REPORTED THAT RESTENOSIS OCCURRED. THE SUBJECT UNDERWENT TREATMENT WITH THE RANGER DRUG COATED BALLOON ON (B)(6) 2023 AS A PART OF THE ELEGANCE CLINICAL TRIAL. THE TARGET LESION WAS IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY EXTENDING UP TO RIGHT MID SUPERFICIAL FEMORAL ARTERY WITH 6.0 MM PROXIMAL REFERENCE VESSEL DIAMETER AND 6.0 MM DISTAL REFERENCE VESSEL DIAMETER WITH LESION LENGTH 150 MM WITH 90% STENOSIS AND WAS CLASSIFIED AS TASC II B LESION. PRIOR TO THE TARGET LESION TREATMENT WITH THE STUDY DEVICE, ATHERECTOMY WAS PERFORMED BY USING 4.0 MM X 120 MM NON-BOSTON SCIENTIFIC (BSC) ATHERECTOMY DEVICE AND PRE-DILATION WAS PERFORMED BY USING 5.0 MM X 100 MM STERLING PTA BALLOON. TREATMENT OF TARGET LESION WAS PERFORMED BY DILATION USING STUDY DEVICE, 6.0 MM X 150 MM RANGER DRUG-COATED BALLOON. FOLLOWING TREATMENT, THE FINAL RESIDUAL STENOSIS WAS NOTED TO BE 5%. ON THE SAME DAY, THE SUBJECT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. ON 17-MAY-2023, SUBJECT WAS NOTED WITH WORSENING SYMPTOMS RELATED TO PERIPHERAL ARTERY DISEASE IN THE RIGHT LEG. ON 07-JUN-2023, 120 DAYS POST INDEX PROCEDURE, 70% STENOSIS NOTED IN THE RIGHT PROXIMAL SUPERFICIAL FEMORAL ARTERY AND RIGHT MID SUPERFICIAL FEMORAL ARTERY WERE TREATED BY ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. THE OUTCOME OF THE EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1233597 RANGER PACLITAXEL-COATED PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU BOSTON SCIENTIFIC CORPORATION 1973-03 02410H22 08714729976189

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other