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

Catalog Number EX061703C

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/02/2017

Event Type  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 specification 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 or image was provided for evaluation.Therefore, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints were reviewed.The reported stent compression may have been caused by an irregular stent placement as a consequence of high deployment forces during stent deployment.Also an unintended movement of the delivery system or excessive compression of the outer catheter during deployment may result in an irregular stent placement.A difficult anatomy of the target vessel or the tracking path may be another contributing factor to the reported event.Insufficient flushing of the device or not performing a pre-dilation also may contribute to this type of event.In this case, it was reported that no pre-dilation was performed.On the basis of the information available and as no sample or image was provided, a definitive root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct stent placement procedure.Also the ifu indicates that the device must be flushed with sterile saline and that pre-dilation of the lesion should be performed by using standard techniques.Furthermore, 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." 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 patient or further procedural 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 during a stent placement procedure for treatment of a distal sfa occlusion of 12 cm length via antegrade approach through the groin, the vascular stent was difficult to deploy by using the thumbwheel and foreshortened to 7 cm during deployment.As reported, no pre-dilation of the lesion had been performed.An additional stent of the same brand was used to cover the lesion completely.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 specification prior to shipment.The subject device was not returned for evaluation; therefore, the reported deployment difficulties could not be verified.On the basis of the evaluation of the images provided, the reported stent foreshortening could be confirmed.The images show a stent implanted in the distal sfa for treatment of an occlusion with the distal part of the stent was foreshortened post stent placement.As reported, the images show a second stent placed in overlapping technique proximal to the first stent.Post-dilation was performed.The blood flow through the vessel was restored.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints were reviewed.The reported stent compression may result from an irregular stent placement caused by high deployment force during stent deployment by using the thumbwheel.Also an unintended movement of the delivery system or excessive compression of the outer catheter during stent deployment may result in an irregular stent placement.A difficult anatomy of the target vessel or the tracking path may be another contributing factor to the reported event.Insufficient flushing of the device or not performing a pre-dilation also may contribute to this type of event.In this case, it was reported that no pre-dilation was performed.On the basis of the information available and the images provided, a definitive root cause for the reported event could not be determined.The ifu supplied with this device sufficiently describes the correct stent placement procedure.Also the ifu indicates that the device must be flushed with sterile saline and that pre-dilation of the lesion should be performed by using standard techniques.Furthermore, 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." updated 'additional event information' due to receipt of images.

Event Description

It was reported that during a stent placement procedure for treatment of a distal sfa occlusion of 12 cm length via antegrade approach through the groin, the vascular stent was difficult to deploy by using the thumbweel and foreshortened to 7 cm during deployment.As reported, no pre-dilation of the lesion had been performed.An additional stent of the same brand was used to cover the lesion completely.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; 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: 6293754
• MDR Text Key: 66277787
• Report Number: 9681442-2017-00042
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 01/03/2017

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 Expiration Date: 04/30/2018
• Device Catalogue Number: EX061703C
• Device Lot Number: ANAR0317
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/03/2017
• Initial Date FDA Received: 02/01/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2016
• 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 Outcome(s): Required Intervention
• Patient Age: 84 YR