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

Catalog Number EX061203C

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/17/2016

Event Type  Injury  

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 patient details.(b)(6).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 after deployment of the vascular stent in a highly calcified lesion from the distal sfa to the popliteal artery via cfa access, the vascular stent was found to be foreshortened and did not cover the lesion completely.Therefore, an additional stent was used to cover the entire lesion and 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.No sample was returned.On the basis of the image provided, the reported stent foreshortening could not be confirmed.The stent strut structure is not visible on the image due to the poor resolution and also a stent compression could not be confirmed.For this reason, the reported event could not be reproduced.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.An unintended movement of the delivery system during stent deployment may result in stent foreshortening.Also excessive compression of the outer catheter during stent deployment or incorrect holding of the delivery system may cause a foreshortening of the stent.A difficult stent placement site and tortuous or calcified anatomy also may contribute to an irregular stent placement.In this case, the target anatomy was reported to be calcified and the tracking path was tortuous.An insufficient pre-dilation of the lesion or the use of a guide wire smaller than recommended in the ifu may be contributing factors to the reported event.In this case, a 0.018" guide wire was used instead of the recommended 0.035" guide wire.On the basis of the information available, a definitive root cause for the reported event could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.Furthermore, the ifu indicates that a 0.035"' guide wire is required for the procedure and that pre-dilation of the lesion should be performed by using standard techniques.(b)(4).

Event Description

It was reported that after deployment of the vascular stent in a highly calcified lesion from the distal sfa to the popliteal artery via cfa access, the vascular stent was found to be foreshortened and did not cover the lesion completely.Therefore, an additional stent was used to cover the entire lesion and to complete the procedure successfully.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: 5945793
• MDR Text Key: 54543435
• Report Number: 9681442-2016-00241
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 08/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: EX061203C
• Device Lot Number: ANZI1402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 79 YR