PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Report
- Report Number
- 2134265-2014-05619
- Event Type
- Injury
- Date Received
- September 16, 2014
- Report Date
- August 26, 2014
- Manufacturer
- BOSTON SCIENTIFIC - GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P110010
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
DEVICE IS A COMBINATION PRODUCT. DEVICE EVALUATED BY MFR: THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).
DEVICE EVALUATED BY MFR: THE STENT HAD DETACHED FROM THE BALLOON. ONLY THE STENT WAS RETURNED FOR ANALYSIS. THE ENTIRE STENT WAS DAMAGED WITH THE STENT STRUTS STRETCHED AND DISTORTED. THE STENT DELIVERY CATHETER WAS NOT RETURNED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE MOST PROBABLE CAUSE OF THE REPORTED DIFFICULTIES MAY BE DUE INTERACTION WITH ANOTHER DEVICE. (B)(4).
IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED AND THE STENT WAS EXPLANTED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED SIZE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS IMPLANTED. SUBSEQUENTLY, A FEW WEEKS AFTER STENT IMPLANTATION, THE PATIENT HAD STENT THROMBOSIS. TO TREAT STENT THROMBOSIS, A NON BSC GUIDEWIRE WAS PLACED IN THE TARGET VESSEL FOLLOWED WITH THE INSERTION OF A NON BSC BALLOON CATHETER AND EVENTUALLY WITH THE INSERTION OF A THROMBECTOMY DEVICE. WHEN THE PHYSICIAN PULLED THE THROMBECTOMY DEVICE, THE IMPLANTED STENT WAS ATTACHED TO THE END OF THE THROMBECTOMY CATHETER. THE PHYSICIAN FIGURED THAT WHEN THE WIRE WAS PLACED, IT WENT THROUGH THE STENT STRUT AND WHEN THE BALLOON CATHETER WAS USED, IT PULLED THE STENT AWAY FROM THE ARTERY. FINALLY, WHEN THE THROMBECTOMY DEVICE WAS USED, THE END OF THE CATHETER "WEDGED" IN THE STENT STRUT AND WHEN IT WAS PULLED, THE STENT FOLLOWED. ALL THE DEVICES WERE REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.
IT WAS REPORTED THAT STENT THROMBOSIS OCCURRED AND THE STENT WAS EXPLANTED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. AN UNSPECIFIED SIZE PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM WAS IMPLANTED. SUBSEQUENTLY, A FEW WEEKS AFTER STENT IMPLANTATION, THE PATIENT HAD STENT THROMBOSIS. TO TREAT STENT THROMBOSIS, A NON BSC GUIDEWIRE WAS PLACED IN THE TARGET VESSEL FOLLOWED WITH THE INSERTION OF A NON BSC BALLOON CATHETER AND EVENTUALLY WITH THE INSERTION OF A THROMBECTOMY DEVICE. WHEN THE PHYSICIAN PULLED THE THROMBECTOMY DEVICE, THE IMPLANTED STENT WAS ATTACHED TO THE END OF THE THROMBECTOMY CATHETER. THE PHYSICIAN FIGURED THAT WHEN THE WIRE WAS PLACED, IT WENT THROUGH THE STENT STRUT AND WHEN THE BALLOON CATHETER WAS USED, IT PULLED THE STENT AWAY FROM THE ARTERY. FINALLY, WHEN THE THROMBECTOMY DEVICE WAS USED, THE END OF THE CATHETER "WEDGED" IN THE STENT STRUT AND WHEN IT WAS PULLED, THE STENT FOLLOWED. ALL THE DEVICES WERE REMOVED COMPLETELY AND THE PROCEDURE WAS COMPLETED. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT'S STATUS WAS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 573465 | PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM | STENT, CORONARY, DRUG-ELUTING | NIQ | BOSTON SCIENTIFIC - GALWAY | UNK717 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |