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

Catalog Number EX061003C

Device Problem Fracture (1260)

Patient Problems Occlusion (1984); Vascular System (Circulation), Impaired (2572)

Event Date 06/10/2014

Event Type  Injury  

Event Description

It was reported that the vascular stent was found to be fractured with reduced blood flow approximately three months post implantation in the sfa.A covered stent was placed successfully for fixation of the fractured stent.No patient injury was reported.

Manufacturer Narrative

Although this product is not sold in the u.S, this event is being reported under regulation 21 cfr part 803 as it involves a similar device to a pma approved device sold in the u.S.Under (b)(4).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.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 evaluation of the angiograms and images provided, a stent fracture can be confirmed.The outer surface of the relevant proximal stented part appeared homogenous with minor irregularities that could not be identified as fracture due to poor strut visibility.Potential factors that could have caused or contributed to the reported issue have been considered.Previous investigations of similar complaints have been reviewed.An irregular stent placement may lead or contribute to a subsequent stent fracture.An inadvertent movement of the hand or incorrect holding of the delivery system during stent release, an insufficient pre or post dilation as well as highly calcified vessels, the patients condition or the vessel anatomy may result in an irregular stent placement and subsequent stent fracture.Based on the information available and the evaluation of the images provided, a definite root cause for the event reported could not be determined.The ifu supplied with this product sufficiently describes the correct application of the device.

• Brand Name: LIFE STENT 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 muellr ; wachhausstrasse 6; karlsruhe ; GM ; 2194450
• MDR Report Key: 4151964
• MDR Text Key: 16304543
• Report Number: 9681442-2014-00129
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: BR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2014
• Device Catalogue Number: EX061003C
• Device Lot Number: ANWF0990
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• 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: 57 YR