MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 02 report with the FDA on 2003-10-01 for CORLINK AAD PROXIMAL 100 manufactured by By-pass Maakafim Ltd..
[354665]
The pt is participating in a marketing study. According to the info received from the surgeon, the bypass performed using corlink proximal device was found to be occluded at angiography test performed 3-month post surgery. Stent procedure is planned to the right coronary artery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003217124-2003-00006 |
| MDR Report Key | 521803 |
| Report Source | 02 |
| Date Received | 2003-10-01 |
| Date of Report | 2003-09-15 |
| Date of Event | 2003-08-15 |
| Date Mfgr Received | 2003-08-20 |
| Device Manufacturer Date | 2002-01-01 |
| Date Added to Maude | 2004-04-26 |
| 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 | MS. LIAT DIAMANT, MGR |
| Manufacturer Street | 2 HASADNAOT STREET |
| Manufacturer City | HERZELIYA 46728 |
| Manufacturer Country | IS |
| Manufacturer Postal | 46728 |
| Manufacturer Phone | 99704324 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | NO |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CORLINK AAD PROXIMAL |
| Generic Name | ANASTOMOTIC DEVICE |
| Product Code | LNN |
| Date Received | 2003-10-01 |
| Model Number | PROXIMAL |
| Catalog Number | 100 |
| Lot Number | SP205, INP 751 |
| ID Number | * |
| Device Expiration Date | 2004-12-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | Y |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 510930 |
| Manufacturer | BY-PASS MAAKAFIM LTD. |
| Manufacturer Address | 3 HASADNAOT STREET HERZELIA IS 46728 |
| Baseline Brand Name | CORLINK AAD PROXIMAL |
| Baseline Generic Name | ANASTOMOTIC DEVICE |
| Baseline Model No | PROXIMAL |
| Baseline Catalog No | 153 |
| Baseline ID | * |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2003-10-01 |