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

Catalog Number EX060803C

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 11/08/2014

Event Type  Injury  

Event Description

It was reported that during deployment of the vascular stent in the sfa, 2/3 of the stent elongated.Post-dilation was performed and another stent was placed across the stretched portion of the stent.No pt 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 device sold in the u.S.Under # p070014.The lot history have been reviewed with special attention to the mfg and inspection of this product and the product was found to have met all specs prior to shipment.During the eval of the returned delivery system, no device deficiency was detected.The deployment mechanism was fully functioning and no defect was found which may have led to a difficult stent deployment and subsequent stent elongation.As no images were provided, the reported stent elongation could not be confirmed.Potential factors which could have led or contributed to the reported event have been considered.Previous investigations of similar complaints have been reviewed.An inadvertent movement of the hand or incorrect holding of the delivery system during stent release, an insufficient pre-dilatation, highly calcified vessels, the pt's condition or the vessel anatomy may result in an irregular stent placement.On the basis of the info available and the eval of the sample, a definite root cause for the reported event 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: 4359791
• MDR Text Key: 5118271
• Report Number: 9681442-2014-00151
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Radiologic Technologist
• Type of Report: Initial
• Report Date: 11/08/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2015
• Device Catalogue Number: EX060803C
• Device Lot Number: ANXL1975
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2014
• Initial Date FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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