MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-03-31 for UNKNOWN XIENCE UNK XIENCE V manufactured by Abbott Vascular.
[185773128]
Dates of death, event, and implant: dates estimated. The device was not returned for evaluation. A review of the lot history record and complaint history of the reported lot could not be conducted because the part and lot number were not provided. The reported patient effect of death is listed in the xience v and xience nano everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling. The additional patient effects referenced will be filed under a separate medwatch report #. The udi is unknown because the part and lot #s were not provided. Article attachment: four-year outcomes of multivessel percutaneous coronary intervention with xience v everolimus-eluting stents.
Patient Sequence No: 1, Text Type: N, H10
[185773129]
It was reported through a research article identifying unk xience v that may be related to the following: myocardial infraction, revascularization, and death. Specific patient information is documented as unknown. Details are listed in the article, titled: four-year outcomes of multivessel percutaneous coronary intervention with xience v everolimus-eluting stents.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03144 |
| MDR Report Key | 9904612 |
| Report Source | LITERATURE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2019-09-01 |
| Date Mfgr Received | 2020-03-12 |
| 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 | UNKNOWN XIENCE |
| Generic Name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Product Code | NIQ |
| Date Received | 2020-03-31 |
| Catalog Number | UNK XIENCE V |
| 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 | 1. Death | 2020-03-31 |