MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-26 for E-LUMINEXX VASCULAR STENT ZVM12060 manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[185175581]
A photo and four images were provided to the manufacturer. The lot number for the device was provided. The device history records are currently under review. The device is not available for return. The investigation is currently underway. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[185175582]
It was reported that during treatment of a moderate to severe stenosis in the calcified common iliac via right groin access, ipsilateral approach, the stent allegedly partially deployed 4-5 cm and the tip of the delivery system allegedly broke and detached within the patient. Reportedly, the detached tip was firmly stuck in the stenosis and the healthcare provider (hcp) attempted to retrieve the detached tip for four hours but was unsuccessful. The patient was taken to the operating room to have the fragment removed and an aortobifemoral prosthetic placed in an open surgery. Reportedly, the patient expired two days post-procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2020-00070 |
| MDR Report Key | 9887043 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-02-27 |
| Date Mfgr Received | 2020-02-28 |
| Device Manufacturer Date | 2018-11-19 |
| Date Added to Maude | 2020-03-26 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Street | WACHHAUSSTRASSE 6 |
| Manufacturer City | KARLSRUHE 76227 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 76227 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | E-LUMINEXX VASCULAR STENT |
| Generic Name | VASCULAR STENT |
| Product Code | NIO |
| Date Received | 2020-03-26 |
| Catalog Number | ZVM12060 |
| Lot Number | ANCX2515 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ANGIOMED GMBH & CO. MEDIZINTECHNIK KG |
| Manufacturer Address | WACHHAUSSTRASSE 6 KARLSRUHE 76227 GM 76227 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2020-03-26 |