FDA Adverse Event
Injury
Summary report: N
TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO
MDR report key: 1910516
·
Received November 19, 2010
Report
- Report Number
- 2953200-2010-02286
- Event Type
- Injury
- Date Received
- November 19, 2010
- Date of Event
- October 26, 2010
- Report Date
- October 26, 2010
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL RESULTS AND CONCLUSION: INADVERTENTLY DELIVERED THE STENT GRAFT INACCURATELY.
Description of Event or Problem · 1
A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. THE ANEURYSM AND VESSELS WERE UNREMARKABLE. IT WAS REPORTED THAT THE CONTRALATERAL LIMB WAS INADVERTENTLY DEPLOYED HIGHER THAN INTENDED. THE DEPLOYMENT WAS FINE THERE WAS NOTHING WRONG WITH THE DEVICE. AN ILIAC EXTENSION WAS REQUIRED TO EXTEND THE STENT GRAFT DOWN TO THE LEVEL OF THE HYPOGASTRIC ARTERY. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO | MIH | MEDTRONIC CARDIOVASCULAR GALWAY | NA | V00504674 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |