N
Patient 1
(B)(4). THE CUSTOMER REPORTED THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.
MAUDE MDR 9861761
- MDR report key
- 9861761
- Report number
- 2024168-2020-02738
- Event key
- 0
- Event type
- 3
- Date of event
- 2020-02-27
- Date received
- 2020-03-20
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 1
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. LINDSEY BELL
- Address
- 26531 YNEZ RD. TEMECULA CA 92591 US
- Phone
- 951-951-9519
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | SUPERA PERIPHERAL STENT SYSTEM | SELF EXPANDING PERIPHERAL STENT SYSTEM | ABBOTT VASCULAR | NIP | S-50-120-120-P6 | S-50-120-120-P6 | 9111461 | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2020-03-20 | 0 | 1. R |
Event Narratives#
D
Patient 1
IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE SEVERELY CALCIFIED RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). PRE-DILATATION WAS PERFORMED. THE 5.0 X 120 MM SUPERA STENT WAS IMPLANTED. THE STENT WAS FULLY DEPLOYED; HOWEVER, AFTER DEPLOYMENT, THE PROXIMAL STENT RECOILED AND SEEMED TO TWIST. THE STENT DELIVERY SYSTEM COULD NOT BE REMOVED. THE PHYSICIAN CHOSE TO REMOVE THE STENT DELIVERY SYSTEM WITH RESISTANCE, RATHER THAN SEND THE PATIENT TO SURGERY. THE NOSE CONE OF THE SUPERA STENT DELIVERY SYSTEM SEPARATED FROM THE DEVICE; HOWEVER, THE STENT DELIVERY SYSTEM WAS ABLE TO BE REMOVED. A STENOTIC AREA WAS CREATED, WHERE THE STENT RECOIL AND TWISTING OCCURRED. ADDITIONAL BALLOON DILATATION WAS PERFORMED AND THE STENT WAS OPENED. A SECOND 5.0 X 80 MM SUPERA STENT WAS IMPLANTED AT THE PROXIMAL STENT. A SNARE DEVICE WAS ABLE TO REMOVE THE SEPARATED NOSE CONE. THE PROCEDURE ENDED WITH ALL VESSELS AND STENTS WIDELY PATENT, AND THE NOSE CONE REMOVED FROM THE PATIENT. POST PROCEDURE, THE PATIENT WAS IN STABLE CONDITION. NO ADDITIONAL INFORMATION WAS PROVIDED.