MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG BARD LUMINEXX 3 VASCULAR STENT

Catalog Number UNK LUMINEXX 3 VASCULAR STENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Unspecified Infection (1930); Sepsis (2067)

Event Date 04/03/2018

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the luminexx 3 vascular stent products that are cleared in the us.The 510 k number and pro code for the luminexx 3 vascular stent products are identified.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: ma, j., luo, j., gu, j., liu, q., liu, l., zhang, w., ¿ yan, z.(2018).Malignant obstructive jaundice treated with intraluminal placement of iodine-125 seed strands and metal stents: an analysis of long-term outcomes and prognostic features.Brachytherapy, 17(4), 689¿695.Doi: 10.1016/j.Brachy.2018.04.001.

Event Description

It was reported in an article from the journal of brachytherapy titled " malignant obstructive jaundice treated with intraluminal placement of iodine-125 seed strands and metal stents: an analysis of long-term outcomes and prognostic features " that therapeutic outcomes and postoperative complications were observed in a retrospective study of 101 patients who were treated with intraluminal placement of 125i seed strands and bare metal stents.Five patients suffered from mild or moderate infection shortly after the operation.Self-limited biliary bleeding developed in 1 patient, liver abscess developed in 5 patients, within 1 month after the operation, liver abscess reoccurred in 1 patient at 6 months after operation, and the patient was treated with abscess drainage.Two patients had severe sepsis that was relieved by anti-infection treatment.Right pleural abscess occurred in 1 patient, which was relieved after drainage and anti-infection treatment.

• Brand Name: BARD LUMINEXX 3 VASCULAR STENT
• Type of Device: VASCULAR 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: 9344955
• MDR Text Key: 167128972
• Report Number: 9681442-2019-00227
• 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: Physician
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK LUMINEXX 3 VASCULAR STENT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2019
• 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
• Patient Outcome(s): Other; Required Intervention