MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2007-10-24 for SYMMETRY AORTIC CONNECTOR BYPASS SYSTEM ACN-UNK manufactured by St. Jude Medical Atg, Inc.
[734683]
According to information received, the pt underwent cabg x2. A saphenous vein graft (svg) was grafted to the ramus intermedius utilizing a sjm symmetry aortic connector proximally for the attachment to the aorta, and the left internal mammary artery (lima) was grafted to the left anterior descending (lad). Approx 7 months postoperatively, the pt developed sob and chest pain. Cardiac catheterization was performed and demonstrated the ramus intermedius branch was occluded proximally and the lima was occluded. Ptca was performed and a stents were placed in the ramus intermedius branch of the left circumflex (cx) and the lad. The pt subsequently underwent additional cardiac cath procedures for occlusion of the svg and lima. In 2006, the pt underwent heart catheterization for complaints of chest pain, was diagnosed with pulmonary hypertension and was discharged in stable condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2135392-2007-00004 |
| MDR Report Key | 931648 |
| Report Source | 00 |
| Date Received | 2007-10-24 |
| Date of Report | 2007-10-24 |
| Date of Event | 2003-02-20 |
| Date Mfgr Received | 2006-07-12 |
| Date Added to Maude | 2007-11-01 |
| 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 RD 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 RD. |
| 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 | 2007-10-24 |
| Model Number | ACN-UNK |
| Catalog Number | ACN-UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 907179 |
| Manufacturer | ST. JUDE MEDICAL ATG, INC |
| Manufacturer Address | MAPLE GROVE MN US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2007-10-24 |