FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 1901590
·
Received November 12, 2010
Report
- Report Number
- 2953200-2010-02232
- Event Type
- Injury
- Date Received
- November 12, 2010
- Date of Event
- May 22, 2012
- Report Date
- February 14, 2013
- Manufacturer
- MEDTRONIC CARDIOVASCULAR GALWAY
- Product Code
- NIQ
- PMA / PMN Number
- P060033
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
EVALUATION, RESULTS: INHERENT RISK OF PROCEDURE - (CVA/STROKE). (B)(4).
Additional Manufacturer Narrative · 1
(B)(4): EVAL RESULTS: (DISSECTION).
Description of Event or Problem · 1
PATIENT EXPERIENCED STROKE/INTERCRANIAL BLEEDING APPROXIMATELY 51 MONTHS POST INDEX PROCEDURE. INVESTIGATOR INDICATED THAT THIS EVENT WAS NOT RELATED TO THE STUDY STENT.
Description of Event or Problem · 1
AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED IN THE MID LAD TO TREAT LESION. ANOTHER ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT WAS IMPLANTED OVERLAPPING TO TREAT COMPLICATIONS OF A DISSECTION AFTER THE INITIAL STENT IMPLANTATION. A THIRD STENT WAS IMPLANTED IN THE 1ST OBTUSE MARGINAL TO TREAT ANOTHER TARGET LESION. AT 1 MONTH, 6 MONTHS, 1 YR, 1.5 YRS, 2 YRS AND 2.5 YRS F/U'S PT WAS ASYMPTOMATIC / FREE OF SYMPTOMS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC CARDIOVASCULAR GALWAY | NA | 0000518121 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 64 YR | Required Intervention |