MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-30 for XIENCE ALPINE 1125300-18 manufactured by Abbott Vascular.
[185729721]
The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
Patient Sequence No: 1, Text Type: N, H10
[185729722]
It was reported that during unpacking of the 3. 0 x 18 mm xience alpine stent delivery system (sds) , the stent was noted to be defective. Therefore, the sds was not used. There was no patient involvement. A new 3. 0 x 18 mm xience alpine sds was used to the complete the procedure. There was no clinically significant delay in the procedure. Return device analysis found a leak coming out from the crack on the hub. No additional information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03103 |
| MDR Report Key | 9899562 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-30 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-18 |
| Date Mfgr Received | 2020-03-09 |
| Device Manufacturer Date | 2019-04-15 |
| 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 ALPINE |
| Generic Name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Product Code | NIQ |
| Date Received | 2020-03-30 |
| Returned To Mfg | 2020-02-12 |
| Model Number | 1125300-18 |
| Catalog Number | 1125300-18 |
| Lot Number | 9040941 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | N |
| 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 |