FDA Adverse Event
Injury
Summary report: N
ACCUTRAK DELIVERY CATHETER SYSTEM
MDR report key: 3821970
·
Received May 20, 2014
Report
- Report Number
- 2025587-2014-00313
- Event Type
- Injury
- Date Received
- May 20, 2014
- Date of Event
- April 9, 2014
- Report Date
- April 25, 2014
- Manufacturer
- MEDTRONIC HEART VALVES DIVISION
- Product Code
- NPT
- PMA / PMN Number
- P130021
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
Additional Manufacturer Narrative · 1
PRODUCT ANALYSIS: THE PRODUCT WAS NOT RETURNED, THEREFORE, NO PRODUCT ANALYSIS CAN BE PERFORMED. CONCLUSION: WITHOUT RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSIONS COULD BE DRAWN REGARDING THE CLINICAL OBSERVATION. PER THE COREVALVE INSTRUCTIONS FOR USE (IFU), ACCESS SITE COMPLICATIONS ARE A POTENTIAL PROCEDURAL COMPLICATION. (B)(4). LOCATION : HOSPITAL.
Description of Event or Problem · 1
MEDTRONIC RECEIVED INFORMATION THAT FOLLOWING THE IMPLANT OF THIS TRANSCATHETER BIOPROSTHETIC VALVE THERE WAS RESTRICTED BLOOD FLOW TO THE RIGHT GROIN AFTER REMOVAL OF THE SHEATH. A BALLOON ANGIOPLASTY WAS PERFORMED AT THE ACCESS SITE. NO OTHER ADVERSE PATIENT EFFECTS WERE REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 300242 | ACCUTRAK DELIVERY CATHETER SYSTEM | AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED | NPT | MEDTRONIC HEART VALVES DIVISION | DCS-C4-18FR | 0006957166 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 00067 YR | Required Intervention |