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

Model Number EX062003CL

Device Problems Failure to Advance (2524); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that during a stent placement procedure in a tortuous and calcified sfa via access through the anterior tibial artery, the stent allegedly failed to cross the lesion through a 5/6f introducer sheath.There was no reported patient injury.

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 the specification prior to shipment.No additional complaint has been previously reported for this lot number.The physical sample was not returned and images were not provided; the alleged deficiency could not be re produced which led to an inconclusive evaluation result.Based on the information available a definite root cause for the reported failure could not be determined.In reviewing the relevant labeling for this product it was found that the instructions for use (ifu) sufficiently addressed the potential risk.The ifu states: 'if resistance is met during stent system introduction, the stent system should be withdrawn and another stent system should be used.' in regards to damage, the ifu states: 'examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.' the ifu demands for 6f introducer sheath.In regards to the access site the ifu states: 'gain femoral access utilizing a 6f (2.0 mm) or larger introducer sheath.'.

Event Description

It was reported that during a stent placement procedure in a tortuous and calcified sfa via access through the anterior tibial artery, the stent allegedly failed to cross the lesion through a 5/6f introducer sheath.There was no reported patient injury.

• Brand Name: LIFESTENT SOLO VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8057108
• MDR Text Key: 127068788
• Report Number: 9681442-2018-00199
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04049519004303
• UDI-Public: (01)04049519004303
• Combination Product (y/n): N
• PMA/PMN Number: P070014
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/29/2019
• Device Model Number: EX062003CL
• Device Catalogue Number: EX062003CL
• Device Lot Number: ANBW3333
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1