FDA Adverse Event
Injury
Summary report: N
PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
MDR report key: 1241718
·
Received November 20, 2008
Report
- Report Number
- 2024168-2008-01195
- Event Type
- Injury
- Date Received
- November 20, 2008
- Date of Event
- October 13, 2008
- Report Date
- October 21, 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
- WI, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THE SECOND UNKNOWN PROMUS (UNKNOWN PART, UNKNOWN LOT) IS BEING FILED UNDER THE SAME MANUFACTURER REPORT NUMBER.
Description of Event or Problem · 1
REPORTING STATUS: SERIOUS INJURY. REPORTING RATIONALE: SUB ACUTE THROMBOSIS. DEVICE ISSUE: NO DEVICE MALFUNCTION HAS BEEN REPORTED. IT WAS REPORTED THAT TWO PROMUS STENTS WERE IMPLANTED; SUBSEQUENTLY, SUB-ACUTE THROMBOSIS OCCURRED. NO ADDITIONAL EVENT OR PATIENT INFORMATION IS AVAILABLE. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES 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 | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization | STENT: UNK PROMUS |