PROMUS ELEMENT ?
Report
- Report Number
- 2134265-2014-02726
- Event Type
- Malfunction
- Date Received
- May 21, 2014
- Date of Event
- April 23, 2014
- Report Date
- April 23, 2014
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- SIMILAR
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE IS A COMBINATION PRODUCT. (B)(4).
DEVICE EVALUATED BY MFR: BASED ON THE POTENTIAL ROOT CAUSES IDENTIFIED AND THE COMPLAINT REPORT, THE FOLLOWING ATTRIBUTES WERE EXAMINED: STENT PROFILE: A VISUAL EXAMINATION OF THE STENT FOUND THAT THE CRIMPED STENT ON THE DEVICE WAS DAMAGED. IT WAS NOTED THAT STENT STRUTS ON THE DISTAL PORTION WERE LIFTED, BUNCHED, STRETCHED AND DEFORMED. THE PROXIMAL END OF THE CRIMPED STENT APPEARED UNDAMAGED. TIP PROFILE: THE BUMPER TIP OF THE DEVICE SHOWED SIGNS OF DAMAGE. BALLOON PROFILE: THE BALLOON CONES PROFILES WERE REVIEWED AND NO ISSUES WERE NOTED WITH THE OVERALL BALLOON PROFILE. THE BALLOON WINGS WERE TIGHTLY WRAPPED AND EVENLY FOLDED AND WERE NOT SUBJECTED TO POSITIVE PRESSURE. HYPOTUBE PROFILE: A VISUAL AND TACTILE EXAMINATION FOUND MULTIPLE KINKS ALONG THE LENGTH OF THE HYPOTUBE. SHAFT POLYMER EXTRUSION PROFILE: A VISUAL AND TACTILE EXAMINATION FOUND NO ISSUES WITH THE PROFILE. 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 STENT DAMAGE OCCURRED. THE 100MM X 2.5MM - 4.0MM, ECCENTRIC, DE NOVO, 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL MID LEFT ANTERIOR DESCENDING ARTERY WITH A SIGNIFICANT BEND OF <=45 DEGREES. FOLLOWING THE ADVANCEMENT OF A NON BSC GUIDE CATHETER AND A NON BSC GUIDEWIRE, THE LESION WAS PREDILATED WITH A 2.5/15 APEX BALLOON CATHETER. SUBSEQUENTLY, A 3.50X24MM PROMUS ELEMENT ¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IN AN ATTEMPT OF REPOSITIONING THE DEVICE, SIGNIFICANT RESISTANCE WAS MET. EVENTUALLY, THE DEVICE WAS REMOVED BUT THE DISTAL SEGMENT OF THE STENT WAS NOTED TO HAVE DIVERGED. STENT DISTAL WAS TWISTED AND SEEMED LIKE THERE WAS A SPLIT. FOLLOWING COMPLETE RETRIEVAL OF THE STENT, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.
IT WAS REPORTED THAT STENT DAMAGE OCCURRED. THE 100MM X 2.5MM - 4.0MM, ECCENTRIC, DE NOVO, 100% STENOSED TARGET LESION WAS LOCATED IN THE MODERATELY TORTUOUS AND MODERATELY CALCIFIED PROXIMAL MID LEFT ANTERIOR DESCENDING ARTERY WITH A SIGNIFICANT BEND OF <=45 DEGREES. FOLLOWING THE ADVANCEMENT OF A NON BSC GUIDE CATHETER AND A NON BSC GUIDEWIRE, THE LESION WAS PREDILATED WITH A 2.5/15 APEX BALLOON CATHETER. SUBSEQUENTLY, A 3.50X24MM PROMUS ELEMENT ¿ DRUG ELUTING STENT WAS ADVANCED TO TREAT THE LESION. HOWEVER, IN AN ATTEMPT OF REPOSITIONING THE DEVICE, SIGNIFICANT RESISTANCE WAS MET. EVENTUALLY, THE DEVICE WAS REMOVED BUT THE DISTAL SEGMENT OF THE STENT WAS NOTED TO HAVE DIVERGED. STENT DISTAL WAS TWISTED AND SEEMED LIKE THERE WAS A SPLIT. FOLLOWING COMPLETE RETRIEVAL OF THE STENT, THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND PATIENT'S STATUS WAS STABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 303739 | PROMUS ELEMENT ? | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493911324350 | 16628907 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 48 YR | BALLOON CATHETER: APEX 2.5/15| GUIDE CATHETER: MACH 1,6FR VL3.5| GUIDE WIRE: ASAHI, MIRACLE 12 |