MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-03-12 for SUPERA PERIPHERAL STENT SYSTEM 42055080-120 manufactured by Abbott Vascular.
[183158608]
The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other incidents. The investigation determined that the reported deployment difficulty and stent shortening were likely the result of anatomical challenges. Forward/pushing motion on the delivery system during stent deployment while attempting to place in the 90% stenosed, moderately tortuous, heavily calcified lesion may have caused shortening of the stent. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
Patient Sequence No: 1, Text Type: N, H10
[183158609]
It was reported that the procedure was performed to treat a 90% stenosed, moderately tortuous, and heavily calcified lesion in the superficial femoral artery. A 6fr 45cm sheath was advanced through the 5. 5mm vessel. Following pre-dilatation with a 5. 5x80mm armada 18 balloon catheter, a 5. 5x80mm supera self-expanding stent system (sess) was advanced. During deployment of the sess the stent became compressed greater than 10% and did not cover the entire lesion. The stent remained within the target lesion and the delivery system was removed under fluoroscopy. A 5. 5x100mm supera stent was deployed overlapping the existing stent to fully cover the lesion. The patient is doing fine. 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 | 2024168-2020-02336 |
| MDR Report Key | 9824677 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-12 |
| Date of Report | 2020-03-12 |
| Date of Event | 2020-02-18 |
| Date Mfgr Received | 2020-02-18 |
| Device Manufacturer Date | 2019-06-13 |
| 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 |
| Catalog Number | 42055080-120 |
| Lot Number | 9061361 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 |