FDA Adverse Event
Malfunction
Summary report: N
INTEGRITY RX CORONARY STENT SYSTEM
MDR report key: 2102990
·
Received May 12, 2011
Report
- Report Number
- 9612164-2011-00416
- Event Type
- Malfunction
- Date Received
- May 12, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- MEDTRONIC IRELAND
- Product Code
- MAF
- PMA / PMN Number
- P030009
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IS
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4). EVAL, RESULTS: (ROOT CAUSE OF EVENT IS UN-DETERMINED DUE TO LIMITED INFO). EVAL SUMMARY: THE FIRST FOURTEEN PROXIMAL STENT SEGMENTS WERE INTACT. THE DISTAL STENT SEGMENTS WERE PULLED IN A DISTAL DIRECTION OVER THE DISTAL TIP.
Description of Event or Problem · 1
THE PHYSICIAN WAS ATTEMPTING TO USE A 2.75 MM DIAMETER X 26 MM LENGTH INTEGRITY RX CORONARY STENT. IT WAS REPORTED THAT THE STENT OF THE RELEVANT DEVICE WAS NOTED TO BE DAMAGED DURING THE PROCEDURE. 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 | 0005279801 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |