MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM

Catalog Number 5F061201C

Device Problems Malposition of Device (2616); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided; therefore, a lot history review is currently being performed.Since the device was not returned and no objective evidence was provided the investigation will remain inconclusive for the reported material deformation and malposition of device.The catalog number identified has not been cleared in the us, but is similar to the lifestent vascular stent products that are cleared in the us.The pro code for the lifestent vascular stent products is identified.Based on the information provided the definitive root cause is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 5f061201c vascular stent experienced a material deformation and malposition of device.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The (b)(6) year old female patient's weight was not provided.

Manufacturer Narrative

H10: the initial mdr submitted for this malfunction inaccurately reported the mdr date of awareness.The correct mdr date of awareness is 03/31/2020.H10: the lot number was provided; therefore, a lot history review is currently being performed.Since the device was not returned and no objective evidence was provided the investigation will remain inconclusive for the reported material deformation and malposition of device.The catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestent vascular stent products that are cleared in the us.The pro code for the lifestent vascular stent products is identified in d2.Based on the information provided the definitive root cause is unknown.The device is labeled for single use.H11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 5f061201c vascular stent experienced a material deformation and malposition of device.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The 85 year old female patient's weight was not provided.

• Brand Name: LIFESTENT 5F 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: 9939988
• MDR Text Key: 187388508
• Report Number: 9681442-2020-00080
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120015
• UDI-Public: (01)00801741120015
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5F061201C
• Device Lot Number: ANCZ1965
• Date Manufacturer Received: 04/21/2020
• Patient Sequence Number: 1