IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER
Report
- Report Number
- 3004066202-2015-00104
- Event Type
- Injury
- Date Received
- March 6, 2015
- Date of Event
- January 1, 2014
- Report Date
- April 20, 2015
- Manufacturer
- INVATEC TECHNOLOGY CENTER GMBH
- Product Code
- ONU
- PMA / PMN Number
- P140010
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- PHYSICIAN
Narratives
AVERAGE AGE OF PATIENTS IN STUDY (AGE RANGE BETWEEN 40-80 YEARS OLD) JOURNAL ARTICLE TITLE: ANGIOLOGY AND VASCULAR SURGERY. VOL. 20. NO. 4/2014 "REMOTE RESULTS OF ANGIOPLASTY USING DRUG-COATED BALLOONS IN LESIONS OF THE FEMOROPOPLITEAL SEGMENT" ZATEVAKHIN, I. I., SHIPOVSKY, V. N., TURSUNOV, S. B., BAGDATYEV, V. YE., DZHURAKULOV, SH. R. SURGICAL DISEASES DEPARTMENT NO. 1 OF THE PAEDIATRIC FACULTY, N. I. PIROGOV RUSSIAN NATIONAL RESEARCH MEDICAL UNIVERSITY, MOSCOW, RUSSIA.
EVALUATION RESULTS: ROOT CAUSE UNKNOWN. INHERENT RISK OF PROCEDURE -RESTENOSIS. NO DEVICE RETURNED. NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED- DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. EVALUATION CONCLUSION: UNABLE TO CONFIRM COMPLAINT - DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW. ROOT CAUSE UNKNOWN; INHERENT RISK OF PROCEDURE - RESTENOSIS. (B)(4). ANGIOLOGY AND VASCULAR SURGERY. VOL. 20 NO4/2014 "REMOTE RESULTS OF ANGIOPLASTY USING DRUG-COATED BALLOONS IN LESIONS OF THE FEMOROPOPLITEAL SEGMENT."
THE AUTHORS ANALYSED THE RESULTS OF BALLOON ANGIOPLASTY USING PACLITAXEL-COATED BALLOONS (IN.PACT ADMIRAL, MEDTRONIC INC., USA) IN P ATIENTS WITH OCCLUSIVE AND STENOTIC LESIONS OF ARTERIES OF THE FEMOROPOPLITEAL SEGMENT. GROUP ONE WAS COMPOSED OF 30 PATIENTS SUBJECTED TO ANGIOPLASTY WITH DRUG-COATED BALLOONS, WHILE GROUP TWO CONSISTED OF 32 PATIENTS UNDERGOING BALLOON ANGIOPLASTY WITH UNCOATED BALLOONS. PRIMARY PATENCY OF THE ANGIOPLASTY ZONE IN PERIODS UP TO 30 MONTHS AFTER THE INTERVENTION USING DRUG-COATED BALLOONS WAS 70% IN GROUP ONE AND 37.5% IN GROUP TWO, WITH THE LIMB-SALVAGE RATE EQUALLING 96.7% AND 87.5%, RESPECTIVELY. IT WAS SHOWN THAT ANGIOPLASTY USING DRUG-COATED BALLOONS IN TREATMENT OF OCCLUSIVE AND STENOTIC LESIONS OF FEMOROPOPLITEAL ARTERIES CONSIDERABLY IMPROVES THE RESULTS OF TREATMENT BY PREVENTING RESTENOSIS OF THE ANGIOPLASTY ZONE IN THE SHORT- AND LONG-TERM PERIODS OF FOLLOW-UP OBSERVATION. IN THE LAST TWO DECADES, THE STRATEGY OF TREATING PATIENTS WITH OCCLUSIVE-STENOTIC LESIONS OF LOWER EXTREMITY ARTERIES HAS FUNDAMENTALLY CHANGED. THIS IS DUE LARGELY TO THE RAPID DEVELOPMENT OF ENDOVASCULAR TECHNOLOGIES. BALLOON ANGIOPLASTY (BA) AND STENTING HAVE BECOME A REAL ALTERNATIVE TO TRADITIONAL OPEN RECONSTRUCTIVE INTERVENTIONS NOT ONLY WHEN THEY ARE IMPOSSIBLE FOR VARIOUS REASONS (SEVERE CONDITION OF THE PATIENT, CONDITION OF OUTFLOW PASSAGES, ETC.), BUT EVEN IN MORE FAVOURABLE SITUATIONS. DRUG-COATED BALLOONS WERE DEVELOPED TO IMPROVE THE BA REMOTE RESULTS AND REDUCE THE FREQUENCY OF RESTENOSIS. HOWEVER, THE SMALL NUMBER OF OBSERVATIONS AND THEIR SHORT PERIODS DO NOT PERMIT THEIR OBJECTIVE EVALUATION AT THIS TIME. THE PURPOSE OF THE STUDY WAS TO COMPARE THE LONG-TERM RESULTS OF BA FOR FEMOROPOPLITEAL LESIONS OF THE ARTERIAL SEGMENT WITH THE USE OF PACLITAXEL-COATED BALLOONS (IN.PACT ADMIRAL, MEDTRONIC INC., USA) AND UNCOATED BALLOONS. RESULTS WERE ANALYSED FROM TREATING TWO GROUPS OF PATIENTS RANGING IN AGE FROM 40 TO 80 WITH OCCLUSIVE-STENOTIC LESIONS OF THE FEMOROPOPLITEAL ARTERIAL SEGMENT OF COMPARABLE NATURE AND SEVERITY. GROUP ONE CONSISTED OF 30 PATIENTS WHO UNDERWENT BA USING DRUG-COATED BALLOONS AND GROUP TWO CONSISTED OF 32 PATIENTS WHO UNDERWENT BA WITH NORMAL BALLOONS. THE PRIMARY CONDITIONS FOR POSSIBLE ANGIOPLASTY WERE: LENGTH OF THE STENOSIS/OCCLUSION LESS THAN 15 CM, GOOD CONDITION OF THE INFLOW PASSAGES AND PRESENCE OF AT LEAST ONE TIBIAL ARTERY PASSABLE TO THE ARCH OF THE FOOT (OR RESTORED THROUGH ANGIOPLASTY). IN GROUP ONE 36.6% OF THE PATIENTS HAD 2B STAGE ISCHAEMIA BY THE FONTAINE-POKROVSKY CLASSIFICATION, 10% HAD STAGE 3, 53.4% HAD STAGE 4 AND IN GROUP TWO, 37.5%, 6.3% AND 56.2% OF THE PATIENTS, RESPECTIVELY. ACCORDING TO THE TASC II CLASSIFICATION, TYPE A LESIONS WERE DIAGNOSED IN 50% OF GROUP ONE PATIENTS AND 43.7% IN GROUP TWO PATIENTS, TYPE B IN 30% AND 28.1%, TYPE C IN 13.3% AND 15.6%, AND TYPE D IN 6.4% AND 12.6% OF THE PATIENTS IN THE TWO GROUPS RESPECTIVELY. THE LESIONS WERE PRIMARILY LOCALISED IN THE MEDIAN AND DISTAL REGIONS OF THE SUPERFICIAL FEMORAL ARTERY (SFA). SFA OCCLUSION WAS DIAGNOSED IN GROUP ONE IN 11 PATIENTS (36.6%), SFA STENOSIS IN 19 (63.4%); IN GROUP TWO, IN 13 (40.6%) AND 19 (59.4%) OF THE PATIENTS, RESPECTIVELY. THE DEGREE OF STENOSIS AVERAGED 89.5% IN GROUP ONE AND 87.3% IN GROUP TWO. AFTER BA SURGERY, ALL PATIENTS IN BOTH GROUPS SHOWED CLINICAL IMPROVEMENT IN THE FORM OF DISAPPEARANCE OF PAINS WHILE RESTING OR INC REASED DISTANCE IN PAIN-FREE WALKING. UPON DISCHARGE, ISCHAEMIA OF THEIR EXTREMITIES WAS ASSESSED AS 2A OR 2B STAGE. THE MEAN TALO-HUMERAL INDEX IN GROUP ONE PATIENTS BEFORE BA SURGERY WAS 0.59 ᠰ.17, UPON DISCHARGE IT WAS 0.79 ᠰ.1; IN GROUP TWO PATIENTS IT WAS 0.49 ᠰ.16 AND 0.69 ᠰ.2 RESPECTIVELY. AMONG GROUP ONE PATIENTS DURING THE FOLLOW-UP PERIOD FROM 6 TO 8 MONTHS, 3% (10%) DEVELOPED RESTENOSIS OF THE RECONSTRUCTED SEGMENT AND 1 (3.3%) SHOWED RE-OCCLUSION WHICH REQUIRED A FEMOROPOPLITEAL BYPASS. IT SHOULD BE NOTED THAT 4 PATIENTS OF BA SURGERY HAD COMPLICATIONS OF INTIMA DISSECTION WHICH REQUIRED ADDITIONAL STENTING. RESTENOSIS (IN 2 PATIENTS) AND RE-OCCLUSION (IN 1 PATIENT) IN THE EARLY FOLLOW-UP PERIODS, AS DESCRIBED ABOVE, DEVELOPED IN PRECISELY THESE PATIENTS. DURING THE FOLLOW-UP PERIOD UP TO 18 MONTHS AFTER BA, ANOTHER 3 GROUP ONE PATIENTS (10%) DEVELOPED RESTENOSIS. WITHIN 24 MONTHS, 1 PATIENT (3.3%) DEVELOPED RE-OCCLUSION WITH CRITICAL ISCHAEMIA RELAPSE. HIS LEG WAS AMPUTATED AT THE THIGH. DURING THE FOLLOW-UP PERIOD UP TO 30 MONTHS, ANOTHER 1 (3.3%) GROUP ONE PATIENT DEVELOPED RE-OCCLUSION WHICH REQUIRED A FEMOROPOPLITEAL BYPASS. THE PATENCY OF GROUP ONE PATIENTS IN THE RECONSTRUCTION ZONE UP TO 30 MONTHS AFTER BA WAS 70%. RESTENOSIS DEVELOPED IN 6 PATIENTS (20%) AND RE-OCCLUSION IN 3 (10%). STENTING WAS PERFORMED ON THREE PATIENTS WITH RESTENOSIS, THE OTHERS RECEIVED CONSERVATIVE TREATMENT DUE TO THE LACK OF CRITICAL ISCHAEMIA. SUCCESSFUL FEMOROPOPLITEAL BYPASS WAS PERFORMED ON TWO OF THE PATIENTS WITH RE-OCCLUSION AND ONE HAD AN AMPUTATION AT THE THIGH LEVEL. IN GROUP TWO DURING THE FOLLOW-UP PERIOD UP TO 6 MONTHS, 9 PATIENTS (28.1%) DEVELOPED RESTENOSIS AND 6 (18.7%) DEVELOPED RE-OCCLUSION WHICH REQUIRED A FEMOROPOPLITEAL BYPASS IN 3 (9.3%) OF THE CASES AND AMPUTATION AT THE THIGH LEVEL IN 3 (9.3%) OF THE CASES. DURING THE FOLLOW-UP PERIOD UP TO 18 MONTHS, ANOTHER 4 (12.5%) OF THE PATIENTS DEVELOPED RESTENOSIS. WITHIN 24 MONTHS, ANOTHER 1 (3.1%) WAS DIAGNOSED WITH RE-OCCLUSION WITH THE DEVELOPMENT OF CRITICAL ISCHAEMIA AND AMPUTATION AT THE THIGH LEVEL WAS PERFORMED. THE PATENCY OF THE ANGIOPLASTY ZONE IN GROUP TWO PATIENTS IN THE PERIOD UP TO 30 MONTHS AFTER BA WAS 37.5%. OF THE 13 PATIENTS WITH RESTENOSIS, A FEMOROPOPLITEAL BYPASS WAS PERFORMED ON 8 AND STENTING ON 5. THERE WERE NO FATALITIES AFTER THE RECONSTRUCTIVE SURGERY. TWO PATIENTS DIED AFTER THE AMPUTATION AT THIGH LEVEL. MYOCARDIAL INFARCT WAS THE CAUSE OF DEATH OF BOTH PATIENTS. OUR RESEARCH RESULTS DEMONSTRATED THAT MOST OF THE RESTENOSIS AND RE-OCCLUSIONS (46.8%) AFTER NORMAL ANGIOPLASTY OF FEMOROPOPLITEAL ARTERIES OCCUR IN THE FIRST 6 MONTHS OF FOLLOW-UP. AFTER ANGIOPLASTY WITH DRUG-COATED BALLOONS IN.PACT ADMIRAL (MEDTRONIC INC., USA), THE RESTENOSIS FREQUENCY IN THESE PERIODS IN OUR OBSERVATIONS WERE ALMOST 4 TIMES LOWER. IT IS ALSO POSSIBLE TO STATE THE STABILITY OF GOOD LONG-TERM RESULTS SINCE WITHIN THE 30 MONTHS OF FOLLOW-UP OBSERVATION, RESTENOSIS WAS ABSENT IN 70% OF THE PATIENTS, WHILE AFTER NORMAL BA THIS WAS ONLY 37.5%. ANGIOPLASTY USING DRUG-COATED BALLOONS FOR OCCLUSIVE-STENOTIC LESIONS OF FEMOROPOPLITEAL ARTERIES THUS SIGNIFICANTLY IMPROVES THE TREATMENT RESULTS BY PREVENTING RESTENOSIS OF THE ANGIOPLASTY ZONE IN THE EARLY AND LONG-TERM FOLLOW-UP PERIODS.
NO AUTHORS LISTED. ABSTRACT THE AUTHORS ANALYSED THE RESULTS OF BALLOON ANGIOPLASTY USING PACLITAXEL-COATED BALLOONS (IN.PACT ADMIRAL, MEDTRONIC INC., USA) IN PATIENTS WITH OCCLUSIVE AND STENOTIC LESIONS OF ARTERIES OF THE FEMOROPOPLITEAL SEGMENT. THE STUDY GROUP WAS COMPOSED OF 30 PATIENTS SUBJECTED TO ANGIOPLASTY WITH DRUG-COATED BALLOONS AND THE CONTROL GROUP CONSISTED OF 32 PATIENTS UNDERGOING BALLOON ANGIOPLASTY WITH UNCOATED BALLOONS. PRIMARY PATENCY OF THE ANGIOPLASTY ZONE WITHIN THE TERMS UP TO 30 MONTHS AFTER THE INTERVENTION USING DRUG-COATED BALLOONS AMOUNTED TO 70% AND IN THE CONTROL GROUP TO 37.5%, WITH THE LIMB-SALVAGE RATE EQUALLING 96.7% AND 87.5%, RESPECTIVELY. IT WAS SHOWN THAT ANGIOPLASTY USING DRUG-COATED BALLOONS IN TREATMENT OF OCCLUSIVE AND STENOTIC LESIONS OF FEMOROPOPLITEAL ARTERIES CONSIDERABLY IMPROVES THE RESULTS OF TREATMENT AT THE EXPENSE OF PREVENTING RESTENOSIS OF THE ANGIOPLASTY ZONE BOTH IN THE SHORT- AND LONG-TERM PERIODS OF FOLLOW UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 159228 | IN.PACT ADMIRAL PACLITAXEL-ELUTING PTA BALLOON CATHETER | CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL | ONU | INVATEC TECHNOLOGY CENTER GMBH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00060 YR | Required Intervention |