MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 1996-11-27 for PRECLUDED IMA SLEEVE UNK manufactured by W.l. Gore Associates, Inc..
[32401]
After implanting the ima sleeve, the dr. Found blood clotting between the pedicle and sleeve, resulting in compression of the pedicle and reduced blood flow through the pedicle. The dr went back, cut open the sleeve and cleared the clot formed there.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2025240-1996-00011 |
| MDR Report Key | 52976 |
| Report Source | 01,05,07 |
| Date Received | 1996-11-27 |
| Date of Report | 1996-11-26 |
| Date Mfgr Received | 1996-10-28 |
| Date Added to Maude | 1996-12-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PRECLUDED IMA SLEEVE |
| Generic Name | IMA SLEEVE |
| Product Code | MFX |
| Date Received | 1996-11-27 |
| Model Number | UNK |
| Catalog Number | UNK |
| Lot Number | UNK |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 53602 |
| Manufacturer | W.L. GORE ASSOCIATES, INC. |
| Manufacturer Address | 3450 W. KILTIE LANE FLAGSTAFF AZ 86001 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-11-27 |