FDA Adverse Event
Injury
Summary report: N
TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO
MDR report key: 2091673
·
Received April 29, 2011
Report
- Report Number
- 2953200-2011-00914
- Event Type
- Injury
- Date Received
- April 29, 2011
- Date of Event
- March 1, 2011
- Report Date
- March 31, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P070027
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL, RESULTS: (STENT GRAFT MIGRATION, ENDOLEAK). RESULTS/CONCLUSION: (DILATED AORTIC NECK).
Description of Event or Problem · 1
A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX FOUR MONTHS AGO. ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE PT PRESENTED AT A ROUTINE FOLLOW-UP APPOINTMENT APPROX ONE MONTH AGO AND A SLIGHT MIGRATION OF THE STENT GRAFT WAS NOTED ON THE ANGIOGRAM WITH THE PRESENCE OF A TYPE I ENDOLEAK. THE STENT GRAFT MIGRATION WAS ATTRIBUTED TO DILATATION OF THE AORTIC NECK. THE PT WAS REFERRED TO ANOTHER PHYSICIAN FOR OPEN SURGICAL REPAIR; HOWEVER; IT IS UNK WHEN AND IF THE PT WILL BE TREATED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO | MIH | MEDTRONIC IRELAND | NA | V00557176 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |