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

Catalog Number ZVM10100

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Death (1802); Edema (1820); Liver Damage/Dysfunction (1954); Vomiting (2144)

Event Date 04/28/2015

Event Type  Death  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.Although this product is not sold in the u.S., this event is being reported under regulation 21cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under #p080007.(b)(4).The information provided by bard 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 bard.

Event Description

It was reported that the stent implantation was successful but the patient expired 8 days after surgery.As reported a transjugular intrahepatic portosystemic shunt procedure (tips procedure) was initially performed to treat a patient liver cirrhosis, portal hypertension and ascites.

Manufacturer Narrative

The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.As part of all complaint investigations, an attempt was made to evaluate the subject device as well as the device usage.In this case, no sample was not returned for evaluation.Three images were provided.Based on the evaluation of the images, no deficiency of the implanted stent was identified.No indication was found that the implanted stent might have contributed to the death of the patient or that the stent has failed to function as intended.Potential contributing factors to the reported event have been evaluated.As the reported event was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.On the basis of the investigation performed, a definite root cause for the reported clinical event could not be determined.According to the ifu supplied with this device, the bard e-luminexx vascular stent is indicated for use in the iliac and femoral arteries.The reported application represents an off-label use of the device.The safety and effectiveness of the device for a treatment as described has not been established.

Event Description

It was reported that the patient expired 14 days post successful implantation of the vascular stent.As reported, the patient presented with a complex medical history including hepatic cirrhosis, portal hypertension and ascitis.The patient underwent a tips procedure as well as a coronary gastric vein embolization.The tips procedure included the implantation of the vascular stent at the level of the portal vein.Reportedly, the patient showed symptoms of vomiting the same day after stent implantation.Transfusions were given and an abdominal paracentesis was performed.The peripheral edema was worsening and serum ammonia levels were increased.The patient expired 14 days after placement of the vascular stent.

• 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 -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: frank kirchner ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 5059628
• MDR Text Key: 25098907
• Report Number: 9681442-2015-00151
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/14/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: ZVM10100
• Device Lot Number: ANWI1763
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2012
• 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): Death
• Patient Age: 73 YR
• Patient Weight: 49