FDA Adverse Event
Death
Summary report: N
BX SONIC STENT DELIVERY SYSTEM (OUS RX)
MDR report key: 776208
·
Received November 1, 2006
Report
- Report Number
- 9616099-2006-01220
- Event Type
- Death
- Date Received
- November 1, 2006
- Date of Event
- March 26, 2004
- Report Date
- November 1, 2006
- Manufacturer
- CORDIS MEXICO
- Product Code
- MAF
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
AN AUTOPSY WAS NOT PERFORMED. ADDITIONAL INFORMATION WILL BE SUBMITTED UPON 30 DAYS OF RECEIPT.
Description of Event or Problem · 1
THE DAY AFTER THE INDEX PROCEDURE THE PATIENT EXPERIENCED A NON Q-MI RELATED TO THE TARGET VESSEL AND THEN SUDDENLY DIED. THE DEATH WAS CLASSIFIED AS CARDIAC. THE PATIENT WAS ADMITTED INTO THE CATH LAB WHERE ANGIOGRAPHY REVEALED 2-VESSEL DISEASE. THE FIRST LESION WAS A 90% STENOSED TYPE B1 MID LEFT ANTERIOR DESCENDING. THE LESION WAS PRE-DILATED WITH A 3.0 X 15MM BALLOON AT 4ATMS. A 3.5 X23MM BX SONIC STENT WAS PLACED AT 12 ATMS. THE SECOND LESION WAS A 90% STENOSED TYPE B1 FIRST DIAGONAL. THE LESION WAS PRE-DILATED WITH A 3.0 X 15MM BALLOON AT 6ATMS. A 3.5 X 18MM BX SONIC STENT WAS PLACED AT 18ATMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BX SONIC STENT DELIVERY SYSTEM (OUS RX) | CORONARY SDS/STENTS | MAF | CORDIS MEXICO | NA | X1003786 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Death | BETA-BLOCKERS| CLOPIDOGREL| CLOPIDOGREL (LOADING DOSE)| PRE-PROCEDURE MEDICATIONS INCLUDE ASA| HEPARIN (8000IU)| ACE-INHIBITORS| INTRA-PROCEDURE MEDICATIONS INCLUDE ASA| NITRATES | |
| 2 | ||||
| 3 | ||||
| 4 | ||||
| 5 | ||||
| 6 |