DUO HYBRID VENOUS STENT SYSTEM
Report
- Report Number
- 3017390540-2024-00003
- Event Type
- Malfunction
- Date Received
- August 1, 2024
- Date of Event
- July 9, 2024
- Report Date
- November 19, 2024
- Manufacturer
- VESPER MEDICAL INC.
- Product Code
- QAN
- PMA / PMN Number
- P230021
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
BLOCK B5: FURTHER INVESTIGATION DETERMINED THAT THIS EVENT IS NO LONGER REPORTABLE. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.
BLOCK A2: THE PATIENT'S DOB IS UNKNOWN. THIS INFORMATION WAS NOT AVAILABLE FROM THE FACILITY. BLOCKS H3/H6: THE DUO DEVICE WAS DISCARDED BY THE FACILITY; THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.
BLOCK B5: ALTHOUGH THIS EVENT REMAINS AS NO LONGER REPORTABLE, THIS SUPPLEMENTAL MDR 2 IS TO CORRECT THE DETAILS IN SUPPLEMENTAL MDR 1. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.
FURTHER INVESTIGATION DETERMINED THAT THE TACK WAS DIFFICULT TO DEPLOY. ALTHOUGH, THE SYSTEM JUMPED FORWARD DURING USE, THE TACK WAS DEPLOYED WITHIN THE DISSECTION PLANE. THERE WAS NO GEOGRAPHIC MISS; THEREFORE, THIS PRODUCT PROBLEM IS NO LONGER REPORTABLE SINCE THERE IS NO POTENTIAL FOR HARM WITH RECURRENCE.
THREE DUO STENT SYSTEM (1 HYBRID, 2 EXTEND) WERE USED IN A THROMBOTIC DISTAL COMMON FEMORAL VEIN. DURING DEPLOYMENT OF THE HYBRID STENT, THE SYSTEM JUMPED FORWARD WITH EVERY TURN OF THE WHEEL, EVEN WHEN THE PHYSICIAN WAS HOLDING BACKWARDS TENSION; HOWEVER, WAS SUCCESSFULLY COMPLETED. IN THE SAME PROCEDURE, THE FIRST EXTEND WAS DEPLOYED BUT ALSO JUMPED FORWARD AND MISSED THE INTENDED MARK OF APPROX. 15 MM SHORT, REQUIRING AN ADDITIONAL STENT (3017390540-2024-00004). A SECOND EXTEND WAS DEPLOYED TO COVER THE REMAINING INTENDED MARK OF APPROX. 15 MM IN LENGTH, BUT ALSO JUMPED FORWARD (3017390540-2024-00005). THE PROCEDURE WAS COMPLETED WITH NO FURTHER STENT REQUIRED AND NO PATIENT INJURY REPORTED. THIS PRODUCT PROBLEM IS BEING REPORTED DUE THE MIS-DEPLOYED STENT. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.
FURTHER INVESTIGATION DETERMINED THAT THE DUO HYBRID STENT WAS DIFFICULT TO DEPLOY. ALTHOUGH, THE DELIVERY SYSTEM JUMPED FORWARD DURING STENT DEPLOYMENT, THE DUO HYBRID STENT WAS DEPLOYED AT THE INTENDED LOCATION. THERE WAS NO STENT GEOGRAPHIC MISS; THEREFORE, THIS PRODUCT PROBLEM IS NO LONGER REPORTABLE SINCE THERE IS NO POTENTIAL FOR HARM WITH RECURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2025430 | DUO HYBRID VENOUS STENT SYSTEM | STENT, ILIAC VEIN | QAN | VESPER MEDICAL INC. | N1101616010120 | 351529 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 89 YR | Female | ASAHI 0.035" GUIDEWIRE| TERUMO: 11F PINNACLE INTRODUCER SHEATH |