FDA Adverse Event
Death
Summary report: N
RESOLUTE INTEGRITY RX
MDR report key: 4349306
·
Received December 22, 2014
Report
- Report Number
- 9612164-2014-01725
- Event Type
- Death
- Date Received
- December 22, 2014
- Date of Event
- December 9, 2014
- Report Date
- May 28, 2015
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- NIQ
- PMA / PMN Number
- P110013
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
DURING THE INDEX PROCEDURE THE PATIENT HAD ONE RESOLUTE INTEGRITY DRUG-ELUTING STENT IMPLANTED IN THE RCA. APPROXIMATELY 21 MONTHS POST, THE INDEX PROCEDURE IT IS REPORTED THAT THE PATIENT SUFFERED FROM CARDIORESPIRATORY FAILURE AND EXPIRED. INVESTIGATOR ASSESSED THAT THE EVENT WAS NOT RELATED TO THE STUDY DEVICE.
Description of Event or Problem · 1
CEC ADJUDICATED THE PATIENT DEATH AS A 'CARDIAC DEATH. CEC LISTED THE CAUSE OF DEATH AS CARDIORESPIRATORY FAILURE WITH UNDERLYING CAUSES OF CAD AND CHF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 841509 | RESOLUTE INTEGRITY RX | STENT, CORONARY, DRUG-ELUTING | NIQ | MEDTRONIC IRELAND | 0006038314 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Death |