FDA Adverse Event
Other
Summary report: N
4.6FX28CM SILHOUETTE SYSTEM W/MONOFILAMENT TETHER
MDR report key: 1728847
·
Received June 8, 2010
Report
- Report Number
- 2027111-2010-00071
- Event Type
- Other
- Date Received
- June 8, 2010
- Date of Event
- June 3, 2010
- Report Date
- June 8, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES CORP.
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
PRODUCT WILL BE RETURNED. F/U WILL OCCUR UNTIL COMPLETION OF INVESTIGATION.
Description of Event or Problem · 1
"BILATERAL STENT EXCHANGE (STENTS REMOVED WERE INDWELLING FOR 6 MONTHS). RIGHT STENT WAS HEAVILY ENCRUSTED AND DIFFICULT TO REMOVE. DR USED LASER TO BREAK UP CALCIFICATION AND REMOVED ALL BUT PROXIMAL CURL OF STENT. PT RETURNING AT LATER DATE FOR PERC PROCEDURE TO REMOVE HEAVY STONE BURDEN AND REMAINDER OF STENT. BOTH STENTS REPLACED WITH SILHOUETTE COMFORT STENTS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 4.6FX28CM SILHOUETTE SYSTEM W/MONOFILAMENT TETHER | NONE | GCJ | APPLIED MEDICAL RESOURCES CORP. | B3838 | 1093233 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |