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

Catalog Number EX070401C

Device Problems Device Operates Differently Than Expected (2913); Packaging Problem (3007)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that after successful implantation, the vascular stent was found to be shorter as labeled on the packaging.This was noticed during post-dilation since the used pta balloon (same labeled size a stent) was longer as the implanted stent.There were no consequences for the pt, the stent covered the lesion sufficiently and no further treatment was necessary.There was no reported pt injury.

Manufacturer Narrative

Although the product is not sold in the u.S., this event is being reported under 21cfr part 803 as it involves a similar device to a pma approved device cold in the u.S., under (b)(4).The device history records are being reviewed.The event is currently under investigation.

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 as specifications 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 was returned.On the basis of the images provided the reported stent foreshortening could not be confirmed as no adequate scaling information was provided so that a length measurement was not possible.Potential factors that could have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The reported event may occur as a result of an inadvertent movement of the hand or incorrect holding of the delivery system during stent release, an insufficient pre-dilatation, highly calcified vessels, the patient's condition or the vessel anatomy.In this case, the lesion was not pre-dilated.The event also may be related to the accessories used since the stent length was measured by a pta balloon which might have had an incorrect length.Based on the information available and the evaluation of the images, a definite root could not be determined.The ifu supplied with this device describes the correct stent deployment.Also the ifu states "pre-dilation of the lesion should be performed using standard techniques.".

• Brand Name: LIFESTENT VASCULAR STENT
• Type of Device: VASCULAR 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: 4804557
• MDR Text Key: 15964962
• Report Number: 9681442-2015-00053
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: EX070401C
• Device Lot Number: ANYL0775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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