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

Catalog Number EX061001C

Device Problems Difficult To Position (1467); Inadequacy of Device Shape and/or Size (1583); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2015

Event Type  Injury  

Event Description

It was reported that post deployment of the vascular stent for treatment of a residual stenosis in the left sfa, it was noticed that the vascular stent did not cover the lesion completely.The stent length was 70mm instead of 100mm.No patient injury was reported.

Manufacturer Narrative

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 sold in the u.S.Under #p070014.The device records are being reviewed.The event is currently under investigation.The information provided by bard represent all of the known information at this time.Despite good faith efforts to obtain additional information, the complaint was unable to provide further patient or procedural details.

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 the specification prior to shipment.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.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 was returned.Based on the investigation of the images received a stent foreshortening could not be confirmed due to poor resolution of the images provided.The stent could not be identified on the images provided.Furthermore, as the delivery system was not returned for evaluation a not visible distal marker could not be verified.Previous investigations of similar complaints have been reviewed to determine the root cause.Potential product and non product related factors which may have contributed to the reported stent foreshortening have been considered.The reported issue of a not visible or missing marker could not be verified as no images addressing this issue were provided and the delivery system was not returned.Based on the information available a definite root cause for the event reported could not be determined.In reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risks.Regarding the position of the radiopaque marker a figure is added to the ifu, which shows the stent without radiopaque markers.The ifu states: "the stent delivery sheath has a radiopaque zone at its distal end.The stent delivery system has a second radiopaque zone proximal to the stent.".Furthermore, the ifu states: "examine the stent and delivery system device for any damage.If it is suspected that the sterility or performance of the device has been compromised, the device should not be used.", and "predilation of the lesion should be performed using standard technique".Corrected age at time of event.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

• Brand Name: LIFESTENT XL VASCULAR STENT
• Type of Device: VASCUALR 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: 4864906
• MDR Text Key: 5864015
• Report Number: 9681442-2015-00076
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: EX061001C
• Device Lot Number: ANYJ2966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 63 YR
• Patient Weight: 90