FDA Adverse Event
Death
Summary report: N
ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION)
MDR report key: 384004
·
Received March 21, 2002
Report
- Report Number
- 2024168-2002-00095
- Event Type
- Death
- Date Received
- March 21, 2002
- Date of Event
- February 22, 2002
- Manufacturer
- GUIDANT VASCULAR INTERVENTION
- Product Code
- LOX
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A PTCI PROCEDURE, AFTER A SUCCESSFUL STENT PLACEMENT IN THE LCX, THE LESION WAS POST-DILATED AND THE POST-DILATATION BALLOON RUPTURED CAUSING A PERFORATION. A PERIOCARDIOCENTESIS WAS PERFORMED. THE ESPRIT WAS THEN ADVANCED TO THE PERFORATION, BUT ITS POSITION WAS MISINTERPRETED AND WAS INADVERTENTLY PLACED DEEPER INTO THE LAD THAN INTENDED (CONTRARY TO IFU). THE BALLOON WAS INFLATED TO 8 ATM, AND A PERFORATION WAS THEN NOTED IN THE MIDDLE LAD. FURTHER ATTEMPTS TO INTERVENE WERE NOT SUCCESFUL. THE PT WAS SENT TO CABG, AND THEN HAD STROKE. REPORTEDLY, THE PT EVENTUALLY DIED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ACS RX ESPRIT CORONARY DILATATION CATHETERS (PERFUSION) | CORONARY DILATATION CATHETERS (PERFUSION) | LOX | GUIDANT VASCULAR INTERVENTION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Death | GUIDE WIRE: FLEXI-WIRE,| GUIDING CATHETER: ZUMA II JCL 8F / BRITE TIP 6F,| STENT: S-670/MULTILINK 4.0X15/STENT GRAFT.| DILATATION CATHETER: ESPRIT 3.0X20, |