MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT XL VASCULAR STENT

Catalog Number EX051501C

Device Problems Difficult or Delayed Positioning (1157); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/27/2016

Event Type  malfunction  

Manufacturer Narrative

The device history records are being reviewed.The event is currently under investigation.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant was unable to provide any further patient details to bard.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 # p070014.

Event Description

It was reported that the vascular stent became compressed during placement in a pre-dilated lesion of the distal sfa at the transition to the popliteal artery via antegrade approach.Reportedly, the vessel section was very calcified.After stent release, the delivery system could not be removed over the 0.035" guide wire.Therefore, the delivery system and guide wire were removed as a single unit.After this, post-dilation with a balloon catheter was performed.Control angiography showed the stent to be foreshortened about 3 cm but the treatment of the target lesion was successful.There was no reported patient injury.

Manufacturer Narrative

The lot 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, a device deficiency could not be identified.The inner assembly of the device and the deployment mechanism were found to be free of damages.There is no indication for the occurrence of increased deployment force.A patency test with the separately returned guide wire could be performed without issue.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.The reported deployment issue may be related to the subsequent difficulties in removing the delivery system over the guide wire and the stent foreshortening identified after deployment.The reported difficulties may be associated with the vessel anatomy or the tracking path.As reported, the lesion was very calcified and the tracking path was reported to be calcified as well.Insufficient flushing of the device or a not performed pre-dilation also may contribute to the reported event.On the basis of the information available and the evaluation of the sample, a definite root cause for the reported event could not be determined.The ifu states: "if excessive force is felt during stent deployment, do not force the stent system.Remove the stent system as possible and replace with a new unit." and "if resistance is met while retracting the delivery system over a guide wire, remove the delivery system and guide wire together." also the ifu indicates that the device must be flushed with sterile saline prior to use.In addition, the ifu states: "remove slack from the delivery system catheter held outside the patient." furthermore, the ifu sufficiently describes the correct application of the device.

Event Description

It was reported that the vascular stent became compressed during placement in a pre-dilated lesion of the distal sfa at the transition to the popliteal artery via antegrade approach.Reportedly, the vessel section was very calcified.After stent release, the delivery system could not be removed over the 0.035" guide wire.Therefore, the delivery system and guide wire were removed as a single unit.After this, post-dilation with a balloon catheter was performed.Control angiography showed the stent to be foreshortened about 3 cm but the treatment of the target lesion was successful.There was no reported patient injury.

• Brand Name: LIFESTENT XL 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: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6131939
• MDR Text Key: 61025779
• Report Number: 9681442-2016-00306
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: EX051501C
• Device Lot Number: ANZA0285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/29/2015
• 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 Age: 72 YR