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

Lot Number ANXL1343

Device Problems Migration or Expulsion of Device (1395); Device Operates Differently Than Expected (2913)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/04/2015

Event Type  Injury  

Event Description

It was reported that during a biliary stenting procedure, during deployment the vascular stent suddenly migrated forward into the duodenum leading to a partial coverage of the malignant stricture.An additional stent was implanted to cover the stricture completely.No patient injury was reported.

Manufacturer Narrative

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

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.There is no indication for a manufacturing-related failure.On the basis of the evaluation of the returned delivery system no device malfunction could be determined.As no images were provided, the reported stent foreshortening could not be verified.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.Minimal changes in stent length may occur during deployment, as stated in the ifu.The stent may become shortened due to the attempt of micro adjustments or unintentional movements of the handle during deployment.The reported application represents an off-label use of the device which also may be a contributing factor.The correct stent dimensions are checked during a 100 % quality control step.Based on the information available, a definitive root cause could not be determined.The ifu states: "the stent experiences minimal length changes during deployment." the ifu indicates a potential stent length change in the table for stent length change information.Also the ifu states: "once the stent is partially or fully deployed, micro-adjustments are no longer possible and the stent should not be dragged or repositioned in the lumen." the ifu also indicates that the device is intended for use in the iliac and femoral arteries.Evaluation completed; updated event problem and evaluation codes.

• Brand Name: E-LUMINEXX VASCULAR STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4814460
• MDR Text Key: 5893390
• Report Number: 9681442-2015-00055
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Lot Number: ANXL1343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• 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
• Patient Age: 74 YR
• Patient Weight: 57