FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM
MDR report key: 2041951
·
Received March 30, 2011
Report
- Report Number
- 9612164-2011-00131
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- February 7, 2011
- Report Date
- March 7, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION RESULTS: GI BLEED. CONCLUSION: BASED ON THE INFORMATION PROVIDED, NO ROOT CAUSE CAN BE DETERMINED.
Description of Event or Problem · 1
TWO ENDEAVOR SPRINT OTW DRUG ELUTING STENTS WERE IMPLANTED; ONE TO THE PROXIMAL RCA AND ONE TO THE DISTAL RCA. FIVE MONTHS POST INDEX PROCEDURE, THE PATIENT WAS ADMITTED TO (B)(6) WITH TARRY STOOLS AND ABDOMINAL PAIN. PATIENT WAS REPORTED TO HAVE A GI BLEED AND ANEMIA. PATIENT RECEIVED 2 UNITS OF PTBCS. AN ESOPHAGOGASTRODUODENOSCOPY FOUND AN ULCER IN THE ANTRUM ON THE STOMACH. PATIENT RECOVERED WITH TREATMENT. INVESTIGATOR REPORTS THAT THE EVENT HAD NO RELATION TO THE DEVICE/PROCEDURE, BUT A POSSIBLE RELATION TO THE DRUG. (MFR# 9612164-2011-00130).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT OTW CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 82 YR | Hospitalization| R |