BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER

    MDR report key: 15779225 · Received November 11, 2022

    Report

    Report Number
    9612164-2022-04191
    Event Type
    Injury
    Date Received
    November 11, 2022
    Date of Event
    April 11, 2022
    Report Date
    November 11, 2022
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    JOURNAL TITLE: OPTIMAL INTRALUMINAL DRUG-COATED BALLOON VERSUS DRUG-ELUTING STENT IN PATIENTS WITH CHRONIC TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY: A RETROSPECTIVE ANALYSIS HTTPS://DOI.ORG/10.1016/J.CARREV.2022.04.002 1553-8389/© 2022 ELSEVIER INC. ALL RIGHTS RESERVED. N. HAYAKAWA, S. KODERA, K. TAKANASHI ET AL. / CARDIOVASCULAR REVASCULARIZATION MEDICINE 43 (2022) 87¿96. AGE: AVERAGE AGE. SEX: MAJORITY GENDER. DATE OF EVENT: DATE ARTICLE ACCEPTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED A JOURNAL ARTICLE TITLED 'OPTIMAL INTRALUMINAL DRUG-COATED BALLOON VERSUS DRUG-ELUTING STENT IN PATIENTS WITH CHRONIC TOTAL OCCLUSION OF THE SUPERFICIAL FEMORAL ARTERY: A RETROSPECTIVE ANALYSIS'. THIS WAS A RETROSPECTIVE STUDY OF CONSECUTIVE PATIENTS WITH FEMOROPOPLITEAL CTO WHO UNDERWENT EVT AT ASAHI GENERAL HOSPITAL FROM JUN E 2018 TO NOVEMBER 2020. THE STUDY PERIOD WAS SELECTED TO ENSURE THAT DATA WERE AVAILABLE FOR ALL SURVIVING PATIENTS FOR AT LEAST ONE YEAR AFTER TREATMENT. A TOTAL OF 824 LESIONS UNDERWENT EVT DURING THE STUDY PERIOD. OF THOSE, A TOTAL OF 246 LESIONS WITH AORTOILIAC LESIONS, BELOW-THE-KNEE LESIONS, AND EVT FOR OTHER DIAGNOSES OTHER THAN PERIPHERAL ARTERIAL DISEASE (PAD), WERE EXCLUDED. A TOTAL OF 497 LESIONS OF FP OCCLUSIVE DISEASE WERE INVESTIGATED. ALL PATIENTS HAD SYMPTOMATIC PAD, WERE CATEGORIZED AS RUTHERFORD CLASS 2¿6, AND HAD AN ANKLE¿ BRACHIAL INDEX (ABI) OF <(><<)>0.9. A TOTAL OF 327 LESIONS WITH A STENOTIC FP LESION, ISOLATED COMMON FEMORAL ARTERY OCCLUSION, ISOLATED POPLITEAL ARTERY OCCLUSION, AND CONTINUOUS OCCLUSION FROM THE ILIAC ARTERY TO THE FEMORAL ARTERY WERE EXCLUDED. NEXT, WE EXCLUDED THE 93 LESIONS WITH SFA CTO WHO WERE TREATED WITH CONVENTIONAL BALLOON ANGIOPLASTY ALONE, BARE NITINOL STENT (BNS), STENT¿GRAFT (SG), OR LOW-DOSE DCB (NOMINAL PACLITAXEL DENSITY OF 2.0 G/MM2 ), AS WELL AS PATIENTS WITH IN-STENT RESTENOSIS AND PATIENTS WITH IN-STENT OCCLUSION LESIONS. PATIENTS WITH SFA CTO ALSO INCLUDED THOSE WITH CONTINUOUS OCCLUSION FROM THE SFA TO THE POPLITEAL ARTERY. FINALLY, WE SORTED THE REMAINING 76 PATIENTS (80 LESIONS) INTO THE FOLLOWING TWO GROUPS: THOSE TREATED WITH HIGH-DOSE DCB (DCB GROUP, N = 43 LESIONS) AND THOSE TREATED WITH DES (DES GROUP, N = 37 LESIONS). THE HIGH-DOSE IN.PACT ADMIRAL DCB (MEDTRONIC VASCULAR, SANTA CLARA, CA, USA) WAS USED. THE ELUVIA DES (BOSTON SCIENTIFIC CORP., MARLBOROUGH, MA, USA) AND ZILVER PTX DES (COOK MEDICAL LLC, BLOOMINGTON, INDIANA, USA) WERE USED. WHETHER A DCB OR A DES WAS USED DEPENDED ON THE OPERATOR'S DECISION IN CONSIDERATION OF THE PRE-DILATION RESULT, THE BACKGROUND OF EACH PATIENT, AND THE CHARACTERISTICS OF THE LESION. IN ALL PATIENTS IN THE DCB GROUP, A DCB WAS USED AFTER CONFIRMING THAT THE RESIDUAL STENOSIS WAS <(><<)>20%, THE DEGREE OF DISSECTION WAS LESS THAN GRADE D, , AND THE PRESSURE GRADIENT OF THE LESION WAS <(><<)>10 MMHG. WE USED DCB FOR THE FULL LENGTH OF LESIONS, THE SIZE OF THE DCB BEING BASED ON THE EXTERNAL ELASTIC MEMBRANE (EEM) LENGTH IN A DISTAL HEALTHY SITE AS DETERMINED BY IVUS MEASUREMENT OR ON THE LUMEN LENGTH BY ANGIOGRAPHY FINDINGS. AFTER TREATMENT, ORAL ADMINISTRATION OF DUAL ANTIPLATELET THERAPY WAS CONTINUED ACCORDING TO THE INSTRUCTION FOR USE OF EACH DCB AND DES. PROCEDURAL SUCCESS WAS DEFINED AS <(><<)>30% RESIDUAL STENOSIS IN THE TREATED LESIONS BY ANGIOGRAPHY SEVERE CALCIFICATION WAS DEFINED AS PACSS GRADE 3 OR 4 . THE PATTERNS OF DISSECTION WERE ANALYZED AND CLASSIFIED BY THREE PHYSICIANS IN THE INSTITUTE. THE PRIMARY ENDPOINT OF THIS STUDY WAS 12-MONTH PRIMARY PATENCY. LOSS OF PATENCY WAS DEFINED AS DUPLEX ULTRASOUND (DUS) PEAK SYSTOLIC VELOCITY RATIO =2.5, A DECREASE IN ABI OF =20% OR >0.15 WHEN COMPARED WITH POSTPROCEDURAL BASELINE, OR STENOSIS IN ANGIOGRAPHY FINDINGS >50%. THE SECONDARY ENDPOINTS WERE12-MONTH FREEDOM FROM CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR) AND 12-MONTH FREEDOM FROM RE-OCCLUSION AS ASSESSED BY DUS OR ANGIOGRAPHY. THE STUDY ENDPOINTS WERE ASSESSED BY ABI, DUS, OR FOLLOW-UP ANGIOGRAPHY AT 12 MONTHS WITH A TOLERANCE OF ±1 MONTH. THE ABI WAS MEASURED AT APPROXIMATELY 1 MONTH, 6 MONTHS, AND 12 MONTHS AFTER THE PROCEDURE. DUS WAS PERFORMED AT APPROXIMATELY 6 MONTHS AND 12 MONTHS AFTER TREATMENT, WHEN CLINICAL SYMPTOMS APPEARED, AND WHEN THE ABI WAS DECREASED BY =20% OR >0.15 COMPARED WITH POSTOPERATIVE BASELINE VALUES. ANGIOGRAPHY WAS PERFORMED WHEN RETREATMENT WAS REQUIRED, WHEN IT WAS NECESSARY TO TREAT ANOTHER LOWER LIMB LESION, OR WHEN OTHER ANGIOGRAPHY WAS REQUIRED. ALL PATIENTS HAD BEEN FOLLOWED UP FOR AT LEAST 12 MONTHS WITH A TOLERANCE OF ±1 MONTH FROM THE DATE OF TREATMENT EXCEPT FOR THOSE WHO HAD DROPPED OUT OF THE STUDY BECAUSE OF DEATH OR OTHER REASONS. ALL PATIENTS WERE NOT BEEN FOLLOWED FOR ONE YEAR, BECAUSE SOME PATIENTS DIED OR LOSS OF FOLLOW UP. THERE WAS NO SIGNIFICANT DIFFERENCE IN THE NUMBER OF PATIENTS WHO WERE ABLE TO BE FOLLOWED UP FOR ONE YEAR BETWEEN THE TWO GROUPS (83.7% VS. 73.0%, P = 0.28). NO LESIONS IN THE DCB GROUP THAT WERE TREATED WITH SUBINTIMAL ANGIOPLASTY; ALL WERE TREATED WITH INTRALUMINAL ANGIOPLASTY. THE BAILOUT STENT RATE WAS 0.0% IN THE DCB GROUP, WHICH MEANT THAT THE LESION WAS ONLY TREATED BY A DCB WITHOUT STENT PLACEMENT. PREDILATION WAS PERFORMED IN ALL CASES, BUT THE PERCENTAGE OF POST-DILATION WAS SIGNIFICANTLY SMALLER IN THE DCB GROUP THAN IN THE DES GROUP. ALL PATIENTS WHO WERE TREATED HAD DISSECTION LESS THAN GRADE D. 12-MONTH PRIMARY PATENCY RATES DID NOT DIFFER SIGNIFICANTLY BETWEEN THE TWO GROUPS (PRIMARY PATENCY: 92.0% VS. 87.2%, P = 0.47). THE RATE OF 12-MONTH FREEDOM FROM CD-TLR ALSO DID NOT DIFFER SIGNIFICANTLY BETWEEN THE TWO GROUPS (97.5% VS. 90.4%, P = 0.22). THE RATE OF 12-MONTH FREEDOM FROM RE-OCCLUSION TENDED TO BE HIGHER IN THE DCB GROUP THAN IN THE DES GROUP (97.5% VS. 87.2%, P = 0.11). THERE WERE NO SIGNIFICANT DIFFERENCES IN THE MAJOR AMPUTATION RATE AND 12-MONTH ALL-CAUSE OF DEATH RATES BETWEEN THE GROUPS. FOR THE DCB GROUP (N = 43) THE STUDY REPORTED 35 DISSECTIONS, 1 CASE OF MAJOR AMPUTATION, 1 DISTAL EMBOLISM AND 3 ALL CAUSE DEATH AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1305779 IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLAS ONU MEDTRONIC IRELAND

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention