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

Catalog Number UNK E-LUMINEXX VASCULAR STENT

Device Problem Obstruction of Flow (2423)

Patient Problems Occlusion (1984); Stenosis (2263); Obstruction/Occlusion (2422)

Event Date 09/24/2017

Event Type  Injury  

Manufacturer Narrative

The catalog number identified has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The 510 k number and pro code for the e-luminexx 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: wan, y.-m., li, y.-h., xu, y., wu, h.-m., li, y.-c., wu, x.-n., & yang, j.-h.(2018).Predictors of shunt dysfunction and overall survival in patients with variceal bleeding treated with transjugular portosystemic shunt creation using the fluency stent graft.Academic radiology, 25(7), 925¿934.Doi: 10.1016/j.Acra.2017.11.020.

Event Description

It was reported in an article from the journal of academic radiology titled " predictors of shunt dysfunction and overall survival in patients with variceal bleeding treated with transjugular portosystemic shunt creation using the fluency stent graft " that stent dysfunction was identified in 63 patients; 30 had shunt stenosis and 33 had shunt occlusion.62 underwent transjugular intrahepatic portosystemic shunt (tips) revisions, including balloon angioplasty, thrombectomy, thromboaspiration, and thrombolysis combined and insertion of one or two new stent grafts and one patient rejected tips revision.The status of the patients was not provided.

Manufacturer Narrative

H10 - the catalog number identified in section d4 has not been cleared in the us but is similar to the e-luminexx vascular stent products that are cleared in the us.The 510 k number and pro code for the e-luminexx vascular stent products are identified in d2 and g5.H10: manufacturing review: the lot number was not reported, a review was not performed.Investigation summary: the sample was not returned for evaluation.Based on images contained in the article no indication could be found that the device or a device deficiency caused or contributed to the complications that occurred during the study which led to an inconclusive evaluation result.Based on the information available the investigation is inconclusive for reported issue.A definite root cause for the reported event could not be determined.The reported application represents an off label use of the device.Labeling review: in reviewing the relevant labeling for this product, it was found that the potential risk is sufficiently addressed.Potential adverse events associated with the use of the bard e-luminexx vascular stent include but may not be limited to the usual complications reported for vascular procedures.However, the reported use of the bard e-luminexx vascular stent for creation of a percutaneous transhepatic intrahepatic portosystemic shunt (ptips) represents an off-label use of the device.According to the instructions for use supplied with this product, the bard e-luminexx vascular stent is indicated for use in the iliac and femoral arteries.Journal article citation: wan, y.-m., li, y.-h., xu, y., wu, h.-m., li, y.-c., wu, x.-n., & yang, j.-h.(2018).Predictors of shunt dysfunction and overall survival in patients with variceal bleeding treated with transjugular portosystemic shunt creation using the fluency stent graft.Academic radiology, 25(7), 925¿934.Doi: 10.1016/j.Acra.2017.11.020.H10: g3, h6(method, conclusion).H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

It was reported in an article from the journal of academic radiology titled " predictors of shunt dysfunction and overall survival in patients with variceal bleeding treated with transjugular portosystemic shunt creation using the fluency stent graft " that stent dysfunction was identified in 63 patients; 30 had shunt stenosis and 33 had shunt occlusion.62 underwent transjugular intrahepatic portosystemic shunt (tips) revisions, including balloon angioplasty, thrombectomy, thromboaspiration, and thrombolysis combined and insertion of one or two new stent grafts and one patient rejected tips revision.The status of the patients was not provided.

• Brand Name: E-LUMINEXX 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: brett curtice ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032772
• MDR Report Key: 9344958
• MDR Text Key: 168102121
• Report Number: 9681442-2019-00231
• 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,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/05/2022

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/30/2019
• Initial Date FDA Received: 11/19/2019
• Supplement Dates Manufacturer Received: 06/08/2022
• Supplement Dates FDA Received: 07/05/2022
• 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): Required Intervention; Other