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

Model Number EX071203CS

Device Problems Break (1069); Difficult or Delayed Positioning (1157); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/27/2017

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 further procedural details to bard.

Event Description

It was reported that during advancement of the delivery system to a severely calcified lesion in the external iliac artery via the right groin and during deployment of the stent, resistance was felt.Therefore, the delivery system was pulled back and the stent deployed but appeared to be foreshortened.An additional stent was placed in overlap with the first stent to complete the procedure successfully.There was no reported patient injury.

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 device and the images provided, the alleged stent foreshortening could not be confirmed.A force transmitting component of the grip was found to be broken.The point in time of the breakage is unknown; the reported resistance upon deployment may have led to the breakage.The thumb slider of the delivery system was found to have been fully activated and functioning upon sample receipt which indicates that the user finalized the deployment by using the thumb slider.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints were reviewed.The stent was difficult to deploy and a component inside the grip was found to be broken.This type of event may be related to a difficult vessel anatomy leading to friction increase and subsequent deployment difficulties.In this case, friction increase was felt during the procedure and the vessel was severely calcified.The alleged stent foreshortening may be a consequence of the difficult deployment.An inadvertent movement of the hand during release force increase, highly calcified vessels, the vessel anatomy, incorrect holding of the delivery system during stent release or an insufficient pre-dilation may be contributing factors to a stent foreshortening.Reportedly, the lesion had been pre-dilated.On the basis of the information available and the evaluation of images and the sample, a definitive root cause for the reported complaint could not be determined.The ifu supplied with this device sufficiently describes the correct stent placement procedure.Also 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 "remove slack from the delivery system catheter held outside the patient." in addition, the ifu indicates that pre-dilation of the lesion should be performed by using standard techniques.

Event Description

It was reported that during advancement of the delivery system to a severely calcified lesion in the external iliac artery via the right groin and during deployment of the stent, resistance was felt.Therefore, the delivery system was pulled back and the stent was deployed but appeared to be foreshortened.An additional stent was placed in overlap with the first stent to complete the procedure successfully.There was no reported patient injury.

• Brand Name: LIFESTENT XL VASCULAR AND BILIARY STENT SYSTEM
• Type of Device: VASCULAR AND BILIARY STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• Manufacturer (Section G): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG -9681442; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstr. 6; karlsruhe 76227 ; GM 76227 ; 0497219445
• MDR Report Key: 6572074
• MDR Text Key: 75363073
• Report Number: 9681442-2017-00185
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519001319
• UDI-Public: (01)04049519001319(17)180930(10)ANAW4191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2018
• Device Model Number: EX071203CS
• Device Catalogue Number: EX071203CS
• Device Lot Number: ANAW4191
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/17/2016
• 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: 53 YR
• Patient Weight: 86