Brand Name | SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM |
Type of Device | BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM |
Manufacturer (Section D) |
BOSTON SCIENTIFIC - GALWAY |
|
|
Manufacturer (Section G) |
BOSTON SCIENTIFIC - GALWAY |
|
|
|
|
Manufacturer Contact |
sonali
arangil
|
one scimed place |
maple grove, MN 55311
|
7634941700
|
|
MDR Report Key | 7151055 |
MDR Text Key | 95929258 |
Report Number | 2134265-2017-12834 |
Device Sequence Number | 1 |
Product Code |
NIQ
|
UDI-Device Identifier | 08714729840183 |
UDI-Public | 08714729840183 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | P150003 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Physician
|
Type of Report
| Initial |
Report Date |
12/11/2017 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 08/14/2018 |
Device Model Number | H7493926020350 |
Device Catalogue Number | 39260-2035 |
Device Lot Number | 0021043056 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
12/11/2017 |
Initial Date FDA Received | 12/28/2017 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 08/31/2017 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Treatment | BALLOON CATHETER: NC TREK 4.0X15MM; BALLOON CATHETER: NC TREK 4.5X8MM |
Patient Outcome(s) |
Required Intervention;
|