MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-08-13 for SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM ACN-UNKNOWN manufactured by St. Jude Medical Atg, Inc..
[674465]
It was reported the patient had a significant history of ischemic cad and previous intervention in 2001, (stenting and angioplasty of the left anterior descending (lad) artery and diagonal-d1, with in-stent restenosis of the angioplasty site). Approx three months later, the patient underwent off-pump cabg x3 with the left internal mammary artery (lima) to lad, and a sjm symmetry connector was utilized for the saphenous vein graft (svg) to the d1. Approx two months later, the patient experienced early svg failure and underwent complex intervention. The svg to the d1 was patient, but severely diseased at the proximal and distal anastomotic areas and was stented. The patient was in stable condition postoperatively.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135392-2007-00002 |
| MDR Report Key | 893127 |
| Report Source | 00 |
| Date Received | 2007-08-13 |
| Date of Report | 2007-08-13 |
| Date of Event | 2001-08-20 |
| Date Mfgr Received | 2007-08-06 |
| Date Added to Maude | 2007-08-16 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | DENISE JOHNSON, RN |
| Manufacturer Street | 177 EAST COUNTY ROAD B |
| Manufacturer City | ST. PAUL MN 55117 |
| Manufacturer Country | US |
| Manufacturer Postal | 55117 |
| Manufacturer Phone | 6514832000 |
| Manufacturer G1 | ST. JUDE MEDICAL ATG, INC. |
| Manufacturer Street | 6500 WEDGWOOD ROAD |
| Manufacturer City | MAPLE GROVE MN 55311 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55311 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM |
| Generic Name | AORTIC CONNECTOR |
| Product Code | NCA |
| Date Received | 2007-08-13 |
| Model Number | ACN-UNKNOWN |
| Catalog Number | ACN-UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 873862 |
| Manufacturer | ST. JUDE MEDICAL ATG, INC. |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-08-13 |