PROMUS ELEMENT? PLUS
Report
- Report Number
- 2134265-2013-03149
- Event Type
- Malfunction
- Date Received
- May 2, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 5, 2013
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P110010
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- PHYSICIAN
Narratives
DEVICE LOT NUMBER, DEVICE EXPIRATION DATE, DEVICE MANUFACTURED DATE - UPDATED. (B)(4).
DEVICE IS A COMBINATION PRODUCT. (B)(4).
DATE OF THIS REPORT ON PREVIOUS REPORT SHOULD HAVE BEEN (B)(4) 2013. DEVICE EVALUATED BY MFR.: A VISUAL AND MICROSCOPIC EXAMINATION FOUND THAT THE STENT WAS DAMAGED. STRUTS ON THE MOST DISTAL ROW WERE BENT OUTWARDS. THE HYPOTUBE WAS SEVERELY KINKED JUST DISTAL TO THE MANIFOLD STRAIN RELIEF. NO ISSUES WERE NOTED WITH THE TIP AND BALLOON OF THE DEVICE THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. THE BALLOON WAS TIGHTLY WRAPPED AND WAS NOT SUBJECTED TO POSITIVE PRESSURE. NO KINKS OR DAMAGE WERE NOTICED ALONG THE REMAINDER OF THE SHAFT OF THE DEVICE. TRACES OF BLOOD WERE VISIBLE IN THE GUIDEWIRE LUMEN INDICATING THE DEVICE WAS USED IN VIVO. SOLIDIFIED CONTRAST MEDIUM WAS VISIBLE IN THE INFLATION LUMEN INDICATING THE DEVICE WAS PREPPED FOR USE. 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 AND/OR PROCEDURAL FACTORS. (B)(4).
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS OBTUSE MARGINAL BRANCH. INITIALLY, THEY PERFORMED PLAIN OLD BALLOON ANGIOPLASTY WITH A BALLOON CATHETER AFTER SUCCESSFULLY ADVANCING A GUIDE WIRE. A 2.25X28MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED BY THE PHYSICIAN BUT FAILED TO CROSS THE TARGET LESION. THE GUIDE WIRE WAS ADVANCED FURTHER AND THEY ATTEMPTED TO RE-ADVANCE THE STENT DELIVERY SYSTEM THROUGH THE TARGET LESION BUT FAILED TO CROSS AGAIN. THE DEVICE WAS REMOVED INTACT BY THE PHYSICIAN. HOWEVER, UPON RETRIEVAL THEY NOTICED THAT THE DISTAL EDGE WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS'S STATUS WAS GOOD.
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS OBTUSE MARGINAL BRANCH. INITIALLY, THEY PERFORMED PLAIN OLD BALLOON ANGIOPLASTY WITH A BALLOON CATHETER AFTER SUCCESSFULLY ADVANCING A GUIDE WIRE. A 2.25X28MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED BY THE PHYSICIAN BUT FAILED TO CROSS THE TARGET LESION. THE GUIDE WIRE WAS ADVANCED FURTHER AND THEY ATTEMPTED TO RE-ADVANCE THE STENT DELIVERY SYSTEM THROUGH THE TARGET LESION BUT FAILED TO CROSS AGAIN. THE DEVICE WAS REMOVED INTACT BY THE PHYSICIAN. HOWEVER, UPON RETRIEVAL THEY NOTICED THAT THE DISTAL EDGE WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS'S STATUS WAS GOOD.
IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, A STENT DAMAGE OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA RADIAL ARTERY. THE 99% STENOSED TARGET LESION WAS LOCATED IN A SEVERELY CALCIFIED AND MODERATELY TORTUOUS OBTUSE MARGINAL BRANCH. INITIALLY, THEY PERFORMED PLAIN OLD BALLOON ANGIOPLASTY WITH A BALLOON CATHETER AFTER SUCCESSFULLY ADVANCING A GUIDE WIRE. A 2.25X28MM PROMUS ELEMENT PLUS STENT DELIVERY SYSTEM WAS ADVANCED BY THE PHYSICIAN BUT FAILED TO CROSS THE TARGET LESION. THE GUIDE WIRE WAS ADVANCED FURTHER AND THEY ATTEMPTED TO RE-ADVANCE THE STENT DELIVERY SYSTEM THROUGH THE TARGET LESION BUT FAILED TO CROSS AGAIN. THE DEVICE WAS REMOVED INTACT BY THE PHYSICIAN. HOWEVER, UPON RETRIEVAL THEY NOTICED THAT THE DISTAL EDGE WAS LIFTED. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENTS'S STATUS WAS GOOD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 191580 | PROMUS ELEMENT? PLUS | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC - GALWAY | H7493918428220 | 15678348 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | GUIDING CATHETER: LUNCHER7FSL4.0| BALLOON CATHETER: BP2.0 X 15| STENT: PROMUS ELEMENT 2.25 X 28| GUIDEWIRE: RUNTHROUGH SIONBLUE |