FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2092757
·
Received May 10, 2011
Report
- Report Number
- 9612164-2011-00389
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- February 2, 2011
- Report Date
- April 11, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVALUATION: RESULTS: MYOCARDIAL INFARCTION AND OCCLUSION.
Description of Event or Problem · 1
ONE 3.5 X 15 ENDEAVOR SPRINT RX DRUG-ELUTING STENT WAS IMPLANTED AT THE LAD. APPROXIMATELY 13 MONTHS LATER, THE PATIENT WAS ADMITTED TO HOSPITAL WITH CHEST PAIN AND PRESSURE. PATIENT UNDERWENT CT ANGIOGRAM TO RULE OUT PULMONARY EMBOLISM. THE PATIENTS TROPONIN PEAKED AT 0.9 CONFIRMING A MYOCARDIAL INFARCTION. PATIENT HAD NO ACUTE ST CHANGES. DURING THE ANGIOGRAM, THE PATIENT EXHIBITED MILD IN-STENT RESTENOSIS OF THE LAD STUDY STENT, BUT NO SIGNIFICANT CORONARY ARTERY DISEASE. THE PATIENT WAS DISCHARGED 3 DAYS LATER WITH UNSTABLE ANGINA. INVESTIGATOR HAS INDICATED THAT IN-STENT RESTENOSIS WAS POSSIBLY RELATED TO THE DEVICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | 0000903568 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Hospitalization |