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

Device Problem Stretched (1601)

Patient Problem Stenosis (2263)

Event Type  malfunction  

Event Description

It was reported that upon deployment, the vascular stent stretched to approximately double its length.As a consequence, the elongated middle section did not have enough radial force to treat the stenosis; therefore, an additional stent was placed to treat that section.There was no report of patient injury.

Manufacturer Narrative

Neither the product catalog number nor the lot number of the subject device has been provided; therefore, 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 & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; 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: 4208854
• MDR Text Key: 4978679
• Report Number: 9681442-2014-00137
• 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: 09/29/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2014
• 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