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 2020-03-31 for RX XIENCE XPEDITION 48 1078300-48 manufactured by Abbott Vascular.
[185725682]
The device was not returned for evaluation. 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 did not indicate a lot specific quality issue. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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
[185725683]
It was reported that the procedure was performed to treat a moderately calcified, moderately tortuous right coronary artery that was 90% stenosed. The 3. 0x48mm xience xpedition stent delivery system (sds) failed to cross due to the anatomy and the shaft kinked after repeated attempts were made. It was then noted that the stent was no longer between the balloon markers but still on the balloon. The sds was removed with the stent still on the balloon. The device was replaced with two non-abbott stents (2. 75x24mm and 3. 0x24mm) to successfully continue the procedure. 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 | 2024168-2020-03131 |
| MDR Report Key | 9903326 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2020-03-11 |
| Date Mfgr Received | 2020-03-11 |
| Device Manufacturer Date | 2019-08-19 |
| Date Added to Maude | 2020-03-31 |
| 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 | RX XIENCE XPEDITION 48 |
| Generic Name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Product Code | NIQ |
| Date Received | 2020-03-31 |
| Catalog Number | 1078300-48 |
| Lot Number | 9081341 |
| 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 | 2020-03-31 |