MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a literature report with the FDA on 2020-02-27 for RX VISION CORONARY STENT SYSTEM UNKNOWN RX VISION manufactured by Abbott Vascular.
[181153858]
Estimated dates: date of death, date of event, date of implant. The udi # could not be provided because the part and lot numbers were not reported. 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 lot and part number were not provided. The investigation was unable to determine a conclusive cause for the reported stent break. A conclusive cause for the reported patient effects and the relationship to the product, if any, cannot be determines. The reported patient effects of stenosis and death, as listed in the multi-link vision coronary stent system (css), instructions for use are known patient effects that may be associated with coronary stenting. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device. The supera and absolute stents referenced are filed under separate medwatch report numbers.
Patient Sequence No: 1, Text Type: N, H10
[181153859]
It was reported through a research article identifying one vision stent that may be related to the following: death, restenosis, target vessel/limb revascularization, stent fracture, stent elongation, and stent compression. Details are listed in the attached article, titled, "comparative outcomes of supera interwoven nitinol vs bare nitinol stents for the treatment of femoropopliteal disease: insights from the xlpad registry".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2024168-2020-01833 |
| MDR Report Key | 9763799 |
| Report Source | LITERATURE |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2016-12-01 |
| Date Mfgr Received | 2020-02-05 |
| Date Added to Maude | 2020-02-27 |
| 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 VISION CORONARY STENT SYSTEM |
| Generic Name | CORONARY STENT DELIVERY SYSTEM |
| Product Code | MAF |
| Date Received | 2020-02-27 |
| Catalog Number | UNKNOWN RX VISION |
| 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 | 2020-02-27 |