FDA Adverse Event
Malfunction
Summary report: N
INTEGRITY RX CORONARY STENT SYSTEM
MDR report key: 2171476
·
Received June 30, 2011
Report
- Report Number
- 9612164-2011-00662
- Event Type
- Malfunction
- Date Received
- June 30, 2011
- Report Date
- June 7, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MAF
- PMA / PMN Number
- P030009
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): EVAL RESULTS: (ROOT CAUSE UNDETERMINED; LIMITED INFO AVAILABLE), (FAILURE TO DELIVER STENT AND STENT DEFORMATION). EVAL SUMMARY: THE HYPOTUBE WAS BENT AND KINKED DISTAL TO THE STRAIN RELIEF. THE DISTAL TIP WAS SEVERELY DAMAGED. THE FIRST DISTAL STENT SEGMENT WAS RAISED, DAMAGED AND DEFORMED. THE SECOND STENT SEGMENT WAS SLIGHTLY RAISED. THE STENT WAS POSITIONED BETWEEN THE MARKER BANDS.
Description of Event or Problem · 1
THE PHYSICIAN WAS USING INTEGRITY RAPID EXCHANGE STENT FOR TREATMENT OF A LESION. IT IS REPORTED THAT THE STENT KINKED. NO CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INTEGRITY RX CORONARY STENT SYSTEM | MAF | MEDTRONIC IRELAND | NA | 0005623172 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |