MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-12 for SUPERA PERIPHERAL STENT SYSTEM S-60-040-120-P6 manufactured by Abbott Vascular.
[183258321]
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[183258322]
It was reported that the procedure was performed to treat a mildly calcified, none tortuous de novo common femoral artery that was 90% stenosed. The 6. 0x40mm supera stent delivery system was advanced with a 6f non-abbott guiding catheter. During deployment, the physician believed the entire length of the stent had been deployed. Heavy resistance was noted during retrieval of the delivery catheter as the stent and tip were trapped in the delivery catheter and subsequently, the tip separated. The remaining proximal end of the stent was deployed in the guiding catheter. The physician attempted to extrude the stent from the guiding catheter but was unsuccessful. The guiding catheter was then dragged in an attempt to release the stent but was unsuccessful. The sheath, stent and separated tip were removed together as a single unit leaving the guidewire in place. A new 6. 5x40mm supera stent was then implanted using the same guiding catheter. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-02386 |
| MDR Report Key | 9826549 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-21 |
| Date Mfgr Received | 2020-02-25 |
| Device Manufacturer Date | 2019-03-11 |
| Date Added to Maude | 2020-03-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. LINDSEY BELL |
| Manufacturer Street | 26531 YNEZ RD. |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal | 925914628 |
| Manufacturer Phone | 9519143996 |
| Manufacturer G1 | ABBOTT VASCULAR, REG # 2024168 |
| Manufacturer Street | 26531 YNEZ ROAD |
| Manufacturer City | TEMECULA CA 925914628 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 925914628 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUPERA PERIPHERAL STENT SYSTEM |
| Generic Name | SELF EXPANDING PERIPHERAL STENT SYSTEM |
| Product Code | NIP |
| Date Received | 2020-03-12 |
| Model Number | S-60-040-120-P6 |
| Catalog Number | S-60-040-120-P6 |
| Lot Number | 9031161 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ABBOTT VASCULAR |
| Manufacturer Address | 26531 YNEZ RD. TEMECULA CA 925914628 US 925914628 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-12 |