MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-03-01 for PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM FG-000001 manufactured by Cardica, Inc..
[1333798]
A (b) (6) female pt operated in (b) (6) 2009, utilizing three pas-port devices during cabg procedure. Pt had severe sternal wound infection and was re-admitted to hosp (b) (6) 2010. Cat scan revealed the presence of aortic pseudoaneurysm. Cath showed entry into pseudoaneurysm with implant attached to the false lumen. Due to concerns about reoperations (sternal infection) the decision was made to repair the hole with a 12mm amplatzer septal occluder device. Deployment was successful.
Patient Sequence No: 1, Text Type: D, B5
[8440287]
The pas-port device was unlikely to be the cause of the event. The observed pseudoaneurysm was likely to be of infectious origin, wherein the aortic wall became dilated (aneurysmatic) right at the implant and has moved the implant away from its original location. Pseudoaneurysms are also known to occur with hand-sewn anastomoses. The vacuum utilized to facilitate wound healing may have been a contributory cause of the aneurysm.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3004114958-2010-00001 |
| MDR Report Key | 1622484 |
| Report Source | 05 |
| Date Received | 2010-03-01 |
| Date of Report | 2010-01-21 |
| Date of Event | 2010-01-21 |
| Date Mfgr Received | 2010-01-21 |
| Date Added to Maude | 2010-03-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MATT CHROUST, DIRECTOR |
| Manufacturer Street | 900 SAGINAW DR. |
| Manufacturer City | REDWOOD CITY CA 94063 |
| Manufacturer Country | US |
| Manufacturer Postal | 94063 |
| Manufacturer Phone | 6503317152 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM |
| Generic Name | CARDIOVASCULAR SURGICAL INSTRUMENT |
| Product Code | NCA |
| Date Received | 2010-03-01 |
| Model Number | NA |
| Catalog Number | FG-000001 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CARDICA, INC. |
| Manufacturer Address | 900 SAGINAW DR. REDWOOD CITY CA 94063 US 94063 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2010-03-01 |