MAUDE Adverse Event Report: ANGIOMED GMBH ADN CO MEDIZINTECHNIK KG LIFESTENT VASCULAR STENT SYSTEM

Catalog Number EX061203CS

Device Problems Detachment Of Device Component (1104); Sticking (1597)

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

Event Date 09/05/2014

Event Type  Injury  

Event Description

It was reported that two stents were placed in overlap in the sfa and upon retraction of the second delivery system, the system got stuck in one of the stents.After manipulation, the delivery system was able to be removed; however, the distal tip of the delivery system detached.The pt was transferred to surgery, where the stented area was blocked off by placement of a graft to bypass the area.The pt was reported to be well post procedure.This complaint addresses the second stent placed.

Manufacturer Narrative

As no lot number was provided, a device history record review could not be performed.The investigation is currently underway.

• Brand Name: LIFESTENT VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH ADN CO MEDIZINTECHNIK KG; karlsruhe ; GM
• Manufacturer (Section G): ANGIOMED GMBH AND CO MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 7622 7; GM 76227
• Manufacturer Contact: daniela mueller ; wachhausstrasse 6; karlsruhe 76227 ; GM 76227 ; 2194450
• MDR Report Key: 4162810
• MDR Text Key: 15350173
• Report Number: 9681442-2014-00132
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P070014/S046
• 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: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EX061203CS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2014
• 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