MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2002-04-10 for ST JUDE MEDICAL ACN 4550 GRAY COLOR CODE manufactured by St Jude Medical.
[229957]
Pt returned to or with copious bleeding into mediastinum post-op day #2 status post cab6x4. Bleed noted at right-sided (pda) graft proximal site and symmetry connector (acn 4550) appeared to be intact. It was unclear whether the bleeding was due to friable aorta at this site or a defect in the saphenous vein graft itself. Repair successful. Pt received multi units packed cells. Post-op day #4 (2) while elevated bun and creatine and possible septic picture, pt arrested. Autopsy showed aortic patch intact, possible thrombus to alom and pda grafts, and complete dehiscence of proximal anastomosis of plom graft likely due to resuscitation efforts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 390877 |
| MDR Report Key | 390877 |
| Date Received | 2002-04-10 |
| Date of Report | 2002-04-03 |
| Date of Event | 2002-02-27 |
| Date Facility Aware | 2002-03-10 |
| Report Date | 2002-04-03 |
| Date Added to Maude | 2002-05-02 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ST JUDE MEDICAL |
| Generic Name | SYMMETRY BYPASS SYSTEM (NITINOL AORTIC CONNECTOR) |
| Product Code | FCP |
| Date Received | 2002-04-10 |
| Model Number | ACN 4550 |
| Catalog Number | GRAY COLOR CODE |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 379924 |
| Manufacturer | ST JUDE MEDICAL |
| Manufacturer Address | ONE LILLEHEI PLAZA ST PAUL MN 55117 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-04-10 |