FDA Adverse Event
Injury
Summary report: N
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1231636
·
Received November 14, 2008
Report
- Report Number
- 2024168-2008-01148
- Event Type
- Injury
- Date Received
- November 14, 2008
- Date of Event
- October 14, 2008
- Report Date
- October 15, 2008
- Manufacturer
- ABBOTT VASCULAR-CARDIAC THERAPIES
- Product Code
- NIQ
- PMA / PMN Number
- P070015
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY/PERMANENT DAMAGE. REPORTING RATIONALE: THROMBOSIS. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT THE PATIENT HAD BEEN DISCHARGED AFTER TREATMENT WITH A PROMUS STENT FOR THROMBOSIS AND WAS HOME; HOWEVER, THE PATIENT EXPERIENCED IN-STENT THROMBOSIS WHICH EMBOLIZED DISTALLY WHICH WAS TREATED WITH MEDICINE ONLY. THE PATIENT WAS NOT BROUGHT BACK TO THE CATH LAB TO BE MEDICALLY TREATED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULAR'S DRUG ELUTING STENT IN THE US.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM | NIQ | ABBOTT VASCULAR-CARDIAC THERAPIES | NA | 8060661 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 60 YR | Disability |