PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2011-00793
- Event Type
- Malfunction
- Date Received
- March 18, 2011
- Date of Event
- February 20, 2011
- Report Date
- February 24, 2011
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- SIMILAR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
PATIENT AGE AT TIME OF EVENT - (B)(6). DEVICE IS A COMBINATION PRODUCT. (B)(4).
DEVICE EVALUATED BY MANUFACTURER - A VISUAL AND MICROSCOPIC EXAMINATION OF THE DEVICE FOUND THE DEVICE WAS RETURNED TO THE COMPLAINT INVESTIGATION SITE WITH THE STENT DISLODGED FROM THE BALLOON AND RESTING ON THE LUMEN OF THE DEVICE. THE STENT WAS DAMAGED AND STRETCHED ALONG IT'S ENTIRE LENGTH. THE STENT LENGTH WAS MEASURED AT 44MM. THE BALLOON WAS FOUND TO HAVE THE STENT IMPRESSIONS ON IT AND PILLOWING OF THE BALLOON INDICATING THAT THE STENT WAS CRIMPED PER PROCESS IN THE CORRECT LOCATION DURING MANUFACTURING. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. THE INNER LUMEN WAS BROKEN AT THE BICOMPONENT WELD RESULTING IN THE DISTAL SECTION OF THE FLEXIBLE SECTION OF THE INNER LUMEN RECOILING AND ACCORDIANING DISTALLY. THE OUTER LUMEN WAS STRETCHED ALONG IT'S ENTIRE LENGTH RESULTING ALSO IN A STRETCH ON THE BALLOON. THIS IS CONSISTENT WITH THE OUTER LUMEN TAKING ALL THE PRESSURE OF THE WITHDRAWAL AFTER THE BREAK AT THE BICOMPONENT WELD. THERE WAS A SEVERE KINK IN THE LUMEN 18MM PROXIMAL TO THE PROXIMAL MARKERBAND. THE TIP WAS STRETCHED TO A TOTAL LENGTH OF 14MM. A PRODUCT MANDREL WAS INSERTED THROUGH THE LUMEN WITH NO RESTRICTIONS NOTED. SOLIDIFIED BLOOD WAS PRESENT WITHIN THE ENTIRE LENGTH OF THE INFLATION LUMEN, THEREFORE INDICATING THE DEVICE HAD BEEN USED IN VIVO. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).
IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED AND THE STENT MOVED ON THE BALLOON. VASCULAR ACCESS WAS OBTAINED THROUGH THE BRACHIAL ARTERY. THE 50% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED MID LEFT CIRCUMFLEX (LCX). DURING ADVANCEMENT OF THE 3.0X28MM PROMUS ELEMENT STENT ON THE UNKNOWN GUIDE WIRE, THE PHYSICIAN FELT 'SOMETHING STUCK'. UPON REMOVAL OF THE GUIDE WIRE AND STENT, THE STENT WAS FOUND TO BE 'NEARLY RIPPED OF THE BALLOON'. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE
IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, A SHAFT FRACTURE OCCURRED AND THE STENT MOVED ON THE BALLOON. VASCULAR ACCESS WAS OBTAINED THROUGH THE BRACHIAL ARTERY. THE 50% STENOSED LESION BEING TREATED WAS LOCATED IN THE MILDLY TORTUOUS AND NON-CALCIFIED MID LEFT CIRCUMFLEX (LCX). DURING ADVANCEMENT OF THE 3.0X28MM PROMUS ELEMENT STENT ON THE UNKNOWN GUIDE WIRE, THE PHYSICIAN FELT 'SOMETHING STUCK'. UPON REMOVAL OF THE GUIDE WIRE AND STENT, THE STENT WAS FOUND TO BE 'NEARLY RIPPED OF THE BALLOON'. THE PROCEDURE WAS COMPLETED WITH ANOTHER PROMUS ELEMENT STENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS IS GOOD. THIS PRODUCT IS ONLY OUS APPROVED BUT IT IS SIMILAR TO AN APPROVED US DEVICE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMUS ELEMENT EVEROLIMUS-ELUTING CORONARY STENT SYSTEM | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493911328300 | 13591871 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |