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 2020-03-30 for XIENCE SIERRA 1550350-18 manufactured by Abbott Vascular.
[185728722]
The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. The investigation determined a conclusive cause for the reported difficulties cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling.
Patient Sequence No: 1, Text Type: N, H10
[185728723]
It was reported that during preparation of a 3. 5x18mm xience sierra stent delivery system (sds), the device was removed from the dispenser coil and the protective sheath was removed; however, it was noted that the stent was off center. The device was not used in the patient and a non-abbott device was used to successfully complete the procedure. There was no clinically significant delay in the procedure and no patient involvement. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03125 |
| MDR Report Key | 9901467 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-03-09 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2018-03-15 |
| Date Added to Maude | 2020-03-30 |
| 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 # 3005718570 (P099) |
| Manufacturer Street | CASHEL ROAD |
| Manufacturer City | CLONMEL TIPPERARY |
| Manufacturer Country | EI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | XIENCE SIERRA |
| Generic Name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Model Number | 1550350-18 |
| Catalog Number | 1550350-18 |
| Lot Number | 8022741 |
| 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 | 2020-03-30 |