FDA Adverse Event
Injury
Summary report: N
EMBOSHIELD EMBOLIC PROTECTION SYSTEM
MDR report key: 731739
·
Received June 29, 2006
Report
- Report Number
- 9616695-2006-00074
- Event Type
- Injury
- Date Received
- June 29, 2006
- Date of Event
- May 26, 2006
- Report Date
- June 1, 2006
- Manufacturer
- ABBOTT IRELAND VASCULAR DIVISION
- Product Code
- NTE
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS NOT RETURNED AND THERE WAS NO LOT INFORMATION. WE WERE NOT ABLE TO PERFORM DEVICE INSPECTION OR DEVICE HISTORY RECORD REVIEW IN THIS CASE.
Description of Event or Problem · 1
ON 05/25/2006, A PHYSICIAN SUCCESSFULLY DEPLOYED AND RETRIEVED AN EMBOSHIELD IN TO THE LEFT INTERNAL CAROTID ARTERY. AN XACT STENT WAS SUCCESSFULLY POSITIONED AND DEPLOYED. A POST-STENT DILATATION WITH ANOTHER BRAND OF BALLOON WAS PERFORMED. NO ADVERSE EVENT OR PATIENT INJURY WAS REPORTED. IT WAS REPORTED THAT ON 05/26/2006, THE PATIENT EXPERIENCED "DIFFICULTY WITH FINE MOVEMENT AND FINGER EXTENSION IN THE RIGH HAND." THERE WAS NO CHANGE IN THE NIH SCORES PER THE NEUROLOGIST. THE PATIENT WAS DISCHARGED HOME WITHOUT INCIDENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | EMBOSHIELD EMBOLIC PROTECTION SYSTEM | PERCUTANEOUS CATHETER | NTE | ABBOTT IRELAND VASCULAR DIVISION | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 75 YR | Required Intervention | ASPIRIN 325MG| CLOPIDOGREL 75MG |