FDA Adverse Event
Injury
Summary report: N
UNK-CV-SR
MDR report key: 7649801
·
Received June 29, 2018
Report
- Report Number
- 2953200-2018-00916
- Event Type
- Injury
- Date Received
- June 29, 2018
- Date of Event
- February 24, 2017
- Report Date
- October 24, 2018
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MIH
- PMA / PMN Number
- P100021
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CH
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Description of Event or Problem · 1
MEDTRONIC RECEIVED THE FOLLOWING INFORMATION OBTAINED FROM THE JOURNAL ARTICLE ENTITLED; LIMB GRAFT OCCLUSION FOLLOWING ENDOVASCULAR AORTIC REPAIR: INCIDENCE, CAUSES, TREATMENT AND PREVENTION IN A STUDY COHORT GUOQUAN WANG, SHUITING ZHAI, TIANXIAO LI, XUAN LI, DANGHUI LU, BO WANG, DONGBIN ZHANG, SHUAITAO SHI, ZHIDONG ZHANG, KAI LIANG, KEWEI ZHANG, XIAOYANG FU, KUN LI AND WEIXIAO LI. DOI: 10.3892/ETM.2017.4658.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 492326 | UNK-CV-SR | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT | MIH | MEDTRONIC IRELAND |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 76 YR | Required Intervention |