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 XIENCE DRUG ELUTING CORONARY STENT UNK UNK RX XIENCE manufactured by Abbott Vascular.
[185702553]
The other additional xience device is being filed under a separate medwatch report number. 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 numbers were not provided. The reported patient effect(s) of myocardial infarction, thrombosis, cerebrovascular accident and death are listed in the xience v everolimus eluting coronary stent systems instructions for use as a known patient effect(s) of coronary stenting procedures. A conclusive cause for the reported death, and the relationship to the product, if any, cannot be determined. However, the treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling. The udi is unknown as the part and lot numbers were not provided. The additional adverse patient effects are being filed under a separate medwatch report#. Article: differential prognostic effect between first- and second-generation drug-eluting stents in coronary bifurcation lesions patient-level analysis of the korean bifurcation pooled cohorts. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185702634]
It was reported through a research article identifying unk xience and unk xience v that may be related to the following: death, myocardial infarction, revascularization, cerebrovascular accident, and stent thrombosis. Specific patient information is documented as unknown. Details are listed in the attached article, titled: differential prognostic effect between first- and second-generation drug-eluting stents in coronary bifurcation lesions patient-level analysis of the korean bifurcation pooled cohorts.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-03127 |
| MDR Report Key | 9903108 |
| Report Source | LITERATURE |
| Date Received | 2020-03-31 |
| Date of Report | 2020-03-31 |
| Date of Event | 2012-08-24 |
| Date Mfgr Received | 2020-03-10 |
| 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 # 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 | XIENCE DRUG ELUTING CORONARY STENT |
| Generic Name | DRUG ELUTING CORONARY STENT DELIVERY SYSTEM |
| Product Code | NIQ |
| Date Received | 2020-03-31 |
| Model Number | UNK |
| Catalog Number | UNK RX XIENCE |
| Lot Number | UNK |
| 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 |