MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG E-LUMINEXX VASCULAR STENT; VASULAR STENT

Catalog Number UNK E-LUMINEXX VASCULAR STENT

Device Problem Obstruction of Flow (2423)

Patient Problem Occlusion (1984)

Event Date 07/28/2008

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: lou, w.-s., gu, j.-p., he, x., chen, l., su, h.-b., chen, g.-p., wang, t.(2009).Endovascular treatment for iliac vein compression syndrome: a comparison between the presence and absence of secondary thrombosis.Korean journal of radiology, 10(2), 135.Doi: 10.3348/kjr.2009.10.2.135.

Event Description

It was reported in an article from korean journal of radiology titled " endovascular treatment for iliac vein compression syndrome: a comparison between the presence and absence of secondary thrombosis " that after stent placement in two iliac vein compression syndrome (ivcs) patients with recurrent dvt present (3 and 6 months after discharge follow-up evaluation showing the in-stent restenosis), blood flow was successfully restored in one case by percutaneous transluminal angioplasty (pta) and not in the other due to the inability to pass the catheter and wire beyond the obstruction.The status of the patients was not provided.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9516533
• MDR Text Key: 172606978
• Report Number: 2020394-2019-05845
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P080007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK E-LUMINEXX VASCULAR STENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/24/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: ASPIRIN 75-300MG OD FOR 6-12 MONTHS; LOW MOLECULAR HEPARIN 4100U FOR 3-5 DAYS; UROKINASE DAILY 250,000-1,000,000U; WARFARIN 1.25 - 5 MG OD FOR 1-6 MONTHS
• Patient Outcome(s): Required Intervention