FDA Adverse Event
Malfunction
Summary report: N
ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2
MDR report key: 1011306
·
Received March 11, 2008
Report
- Report Number
- 2953200-2008-00115
- Event Type
- Malfunction
- Date Received
- March 11, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 12, 2008
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CT, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
RESULT, CONCLUSION: (LACK OF INFO AND DEVICE NOT RETURNED FOR EVAL.
Description of Event or Problem · 1
AN UNK SIZE ENDEAVOR MX2 DRUG-ELUTING CORONARY STENT DELIVERY SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN UNK LESION. THE VESSEL MORPHOLOGY WAS NOT REPORTED. IT IS UNK IF THE LESION WAS PRE-DILATED. IT WAS REPORTED THAT THE ENDEAVOR DRUG-ELUTING STENT DELIVERY SYSTEM WAS INSERTED AND THE STENT WAS SUCCESSFULLY DEPLOYED AT THE LESION SITE. THE PHYSICIAN ATTEMPTED TO REMOVE THE DELIVERY SYSTEM AND MET WITH SOME RESISTANCE WHEN BRINGING BACK INTO THE GUIDE CATHETER. AFTER SEVERAL MINS, THE STENT DELIVERY SYSTEM WAS SUCCESSFULLY REMOVED. THE DEVICE HAS BEEN DISCARDED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT MX2 | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |