FDA Adverse Event
Injury
Summary report: N
ENDEAVOR SPRINT RX CORONARY STENT SYSTEM
MDR report key: 2092745
·
Received May 10, 2011
Report
- Report Number
- 9612164-2011-00395
- Event Type
- Injury
- Date Received
- May 10, 2011
- Date of Event
- April 1, 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
- KY, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4): EVALUATION: RESULTS: (REACTION), OTHER: (NO CONCLUSION CAN BE DRAWN BASED ON INFORMATION PROVIDED TO DATE).
Description of Event or Problem · 1
APPROX THREE MONTHS POST IMPLANT OF AN ENDEAVOR SPRINT RAPID EXCHANGE (RX) DRUG-ELUTING STENT, THE PT BELIEVED THAT HE WAS EXPERIENCING A REACTION. THE SYMPTOMS WERE RESPIRATORY RELATED, WITH A CHOKING FEELING. THE PT HAD THREE OTHER STENTS IMPLANTED, PRIOR TO IMPLANTATION OF THE ENDEAVOR SPRINT STENT, TWO IN THE CARDIOVASCULATURE AND ONE IN THE KIDNEY. THE PT ALSO INDICATED THAT HE HAS MANY ALLERGIES, ESPECIALLY TO ACRYLICS AND POLYMERS. THE PT'S SYMPTOMS SUBSIDED ONE MONTH POST STENTING PROCEDURE, AND IS FEELING BETTER NOW. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDEAVOR SPRINT RX CORONARY STENT SYSTEM | NIQ | MEDTRONIC IRELAND | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |