PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2024168-2013-01846
- Event Type
- Death
- Date Received
- April 1, 2013
- Date of Event
- January 1, 2011
- Report Date
- February 25, 2013
- Manufacturer
- AV-TEMECULA-CT
- Product Code
- NIQ
- PMA / PMN Number
- P070015
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GR
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
(B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US. THE STENTS REMAIN IN THE PATIENTS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE REPORTED ADVERSE PATIENT EFFECTS, OTHER THAN DEATH, ARE REPORTED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. THE UNKNOWN XIENCE V STENT IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. RESULTS: OVERALL EVENT-FREE SURVIVAL WAS SIGNIFICANTLY IMPROVED. PRIMARY EES PLACEMENT IN THE INFRAPOPLITEAL ARTERIES FOR CLI TREATMENT EXHIBIT SINGLE-DIGIT NNT AND RELATIVELY LOW CORRESPONDING ICERS. THE MEAN EVENT-FREE SURVIVAL GAINED PER PATIENT WAS 0.91 YEARS. THE AVERAGE COST SAVINGS PER EVENT-FREE LIFE YEAR GAINED IS 11,581 EUROS. CLINICAL AND ANGIOGRAPHIC OUTCOMES: THERE WAS NO MAJOR PROCEDURE-RELATED ADVERSE EVENT IN EITHER OF THE STUDY GROUPS DURING THE IMMEDIATE OR 30-DAY POST-PROCEDURE PERIOD. AS A RESULT OF THE IMPROVED FEMOROPOPLITEAL AND INFRAPOPLITEAL PRIMARY PATENCY ACHIEVED IN THE XIENCE AND PROMUS GROUP, TARGET LESION REVASCULARIZATION (TLR) EVENTS WERE SIGNIFICANTLY FEWER AND OVERALL PATIENT EVENT-FREE SURVIVAL WAS IMPROVED COMPARED TO THE CONTROL GROUP (BAIL OUT PROCEDURES). AT 3 YEARS, INFRAPOPLITEAL TLR-FREE SURVIVAL WAS SIGNIFICANTLY HIGHER IN THE GROUP OF EVEROLIMUS-TREATED LESIONS VERSUS THE CONTROL GROUP. PRIMARY STENTING OF LONG INFRAPOPLITEAL LESIONS WITH EVEROLIMUS-ELUTING STENTS SIGNIFICANTLY INHIBITS RESTENOSIS AND IMPROVES PRIMARY PATENCY WITH SUSTAINED CLINICAL IMPROVEMENT. PATIENTS TREATED WITH PRIMARY EVEROLIMUS-ELUTING STENTING HAD LESS CLINICALLY-DRIVEN REVASCULARIZATION AND SIGNIFICANTLY BETTER EVENT-FREE SURVIVAL. WHILE IN 47 PATIENTS, CLI FOR INFRAPOPLITEAL LESIONS WAS TREATED VIA IMPLANTATION OF EES, 34 PATIENTS (IT UNKNOWN IF SOME OF THE 34 PATIENTS COMPRISE THE 47 PATIENTS THAT RECEIVED EES) RECEIVED PLAIN BALLOON ANGIOPLASTY AND BAIL-OUT BARE METAL STENTS AS NECESSARY FOR A TOTAL OF 36 LIMBS TREATED WITH SOME OF THESE LIMBS CONTAINING A TOTAL OF 86 UNSPECIFIED BARE METAL STENTS; THIS SUGGESTS THAT THE EES (XIENCE V STENTS) WERE UNABLE TO RECANALIZE CRITICAL LIMBS OF 34 PATIENTS AS ALTERNATE TREATMENT WAS REQUIRED. WITH MAJOR EVENTS DEFINED AS DEATH, MAJOR AMPUTATION, RESTENOSIS, AND ISCHEMIA-DRIVEN TARGET LIMB REPEAT PROCEDURES, THIS STUDY INDICATES THAT WITHIN 3 YEARS (WITH THE REFERENCED STUDY PUBLISHED 2011), A TOTAL OF 17 UNSPECIFIED EVENTS OCCURRED IN THE 47 PATIENTS THAT RECEIVED A TOTAL OF 332 EES. THE EVENT OF DEATH WILL BE REPRESENTED IN THIS REPORT, WHILE THE OTHER ADVERSE PATIENT EFFECTS ARE REPORTED UNDER A SEPARATE MANUFACTURING NUMBER. NO ADDITIONAL INFORMATION WAS NOTED.
(B)(4). THERE WAS NO REPORTED PRODUCT DEFICIENCY AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECT OF DEATH, IS LISTED IN THE XIENCE V INSTRUCTIONS FOR USE, AND IS A KNOWN ADVERSE EVENT ASSOCIATED WITH USE OF A CORONARY STENT IN NATIVE CORONARY ARTERIES. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE STATES: THE XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH LESS THAN OR EQUAL TO 28 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM - 4.0 MM.
THIS EVENT WAS CAPTURED BASED ON REVIEW OF THE TWO RELATED FOLLOWING ARTICLES: COST-EFFECTIVENESS ANALYSIS OF INFRAPOPLITEAL DRUG-ELUTING STENTS, CARDIOVASCULAR INTERVENTIONAL RADIOLOGY (2013) 36:90-97 PUBLICATION (PUBLISHED 14 MARCH 2012 BY SPRINGER SCIENCE+BUSINESS MEDIA, LLC AND THE CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGICAL SOCIETY OF EUROPE (CIRSE) 2012). PRIMARY EVEROLIMUS-ELUTING STENTING VERSUS BALLOON ANGIOPLASTY WITH BAILOUT BARE METAL STENTING OF LONG INFRAPOPLITEAL LESIONS FOR TREATMENT OF CRITICAL LIMB ISCHEMIA. J ENDOVASC THER 18(1):1-12 (2011). BACKGROUND: PARTICULAR PROMISE HAS SHOWN THE USE OF EVEROLIMUS-ELUTING STENTS (EES) FOR THE RECANALIZATION OF RELATIVELY LONG INFRAPOPLITEAL OCCLUSIONS FOR CRITICAL LIMB ISCHEMIA (CLI) BY SIGNIFICANTLY IMPROVING ANGIOGRAPHIC LONG-TERM PATENCY, REDUCING INFRAPOPLITEAL RESTENOSIS, AND THEREBY LESSENING THE RATE OF ISCHEMIA-DRIVEN REPEAT INTERVENTIONS. HOWEVER, COST-UTILITY ISSUES OF INFRAPOPLITEAL DES HAVE STILL NOT BEEN ADEQUATELY EXPLORED. METHOD: THE EVENT-FREE INDIVIDUAL SURVIVAL OUTCOMES (DEFINED BY THE ABSENCE OF ANY MAJOR EVENTS, INCLUDING DEATH, MAJOR AMPUTATION, AND ISCHEMIA-DRIVEN TARGET LIMB REPEAT PROCEDURES), WERE RECONSTRUCTED ON THE BASIS OF THE PUBLISHED INFRAPOPLITEAL 2ND ARTICLE REFERENCED ABOVE: FULL-LESION PRIMARY EVEROLIMUS-ELUTING STENTING (EES) VERSUS PLAIN BALLOON ANGIOPLASTY FOR 47 CLI PATIENTS WITH 51 LIMBS TREATED WITH A TOTAL OF 332 EES STENTS VERSUS BAIL-OUT BARE METAL STENTING AS NECESSARY (AND AS CONTROL GROUP). A CLI POPULATION WAS TREATED IN BOTH CASES WITH THE PRIMARY AIM OF LIMB SALVAGE. THE NUMBER-NEEDED-TO-TREAT (NNT) TO AVOID ONE MAJOR EVENT AND INCREMENTAL COST-EFFECTIVENESS RATIOS (ICERS) WERE CALCULATED FOR A 3-YEAR POST-PROCEDURAL PERIOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 132299 | PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM | DRUG ELUTING CORONARY STENT SYSTEM | NIQ | AV-TEMECULA-CT |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Death |