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

Catalog Number EX061703C

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 02/27/2015

Event Type  Injury  

Event Description

It was reported that after implantation of the vascular stent in the sfa, the stent was found to be shorter than expected without any irregularities of the stent structure.Therefore, an additional stent was deployed which was also found to be shorter than expected.A third stent was then used to complete the procedure successfully.No patient injury was reported.This is the same patient as reported in medwatch report # 9681442-2015-00034.

Manufacturer Narrative

Although this product is not sold in the u.S., this event is being reported under regulation 21 cfr 803 as it involves a similar device to a pma approved device sold in the u.S.Under #p070014.Since the lot number of the subject device was not provided, a device history record review could not be performed.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 received it could not be confirmed that the stent is too short because an adequate scaling information was not provided.Furthermore, the stent strut structure is not visible on the images.Potential factors that could have contributed to the reported event have been considered.As the reported event was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.Correct stent dimension is checked during a 100% control step during the stent loading process and during a final quality control step prior to release for distribution.Based on the information available and the evaluation of the images provided, a definite root cause could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.

• 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 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4739640
• MDR Text Key: 5706883
• Report Number: 9681442-2015-00033
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: TW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061703C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 82 YR
• Patient Weight: 80