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

Device Problem Material Deformation (2976)

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

Event Date 09/16/2014

Event Type  Injury  

Event Description

It was reported that during a vascular stenting procedure of the left sfa, the vascular stent elongated during post-dilation with a pta balloon.The elongated stent was dilated once more with a new balloon in order to avoid any strut misplacement inside the vessel lumen.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.As neither the product catalog number nor the lot number of the subject device has been provided, a device history record review could not be performed.

• 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: 4265580
• MDR Text Key: 18264762
• Report Number: 9681442-2014-00141
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2014
• 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
• Patient Age: 53 YR
• Patient Weight: 79