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 2020-03-26 for LIFESTENT STENT SYSTEM EX071503CS manufactured by Angiomed Gmbh & Co. Medizintechnik Kg.
[187057642]
An image was 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. (expiry date: 07/2020).
Patient Sequence No: 1, Text Type: N, H10
[187057663]
It was reported that one day after placement in the calcific superficial femoral artery containing thrombus via contralateral calcified common femoral approach, the stent was found fractured in two places. It was further reported that a stent graft was used to reline the fractured area of the stent in an additional procedure. The patient is reportedly stable.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681442-2020-00069 |
| MDR Report Key | 9886898 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date of Event | 2020-03-02 |
| Date Mfgr Received | 2020-03-02 |
| Device Manufacturer Date | 2018-07-30 |
| 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 | LIFESTENT STENT SYSTEM |
| Generic Name | VASCULAR AND BILIARY STENT |
| Product Code | FGE |
| Date Received | 2020-03-26 |
| Model Number | EX071503CS |
| Catalog Number | EX071503CS |
| Lot Number | ANCU1789 |
| 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. Required No Informationntervention | 2020-03-26 |