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

Catalog Number 5F060401C

Device Problems Failure to Advance (2524); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the device was provided; therefore, a lot history review is currently being performed.The sample was returned to the manufacturer for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.The catalog number identified has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code for the lifestent 5f vascular stent system products is identified.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5f060401c vascular stent system allegedly experienced malposition of the device.This information was received from one source.One patient was involved with no patient consequence.Age, weight, and gender were not provided for the patient.

Manufacturer Narrative

H10: for the reported event, lot number was provided, and lot history review.The sample was returned for evaluation.Based on the investigation of the returned catheter sample an advancing issue could not be confirmed.Deformation/ damage directly related to an advancing issue could not be found.A root cause has not been determined.The device was labeled for single use.The catalog number identified in section d4 has not been cleared in the us, but is similar to the lifestent 5f vascular stent system products that are cleared in the us.The pro code for the lifestent 5f vascular stent system products is identified in d2.H10: g4, h6 (device : 2524).H11: g1, h6 (result, conclusion).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 indicated that model 5f060401c vascular stent system allegedly experienced malposition of the device.This information was received from one source.One patient was involved with no patient consequence.Age, weight, and gender were not provided for the patient.

• Brand Name: LIFESTENT 5F VASCULAR STENT SYSTEM
• Type of Device: VASCULAR STENT SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 9939259
• MDR Text Key: 187391423
• Report Number: 9681442-2020-00077
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119972
• UDI-Public: (01)00801741119972
• 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: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 5F060401C
• Device Lot Number: ANDQ1804
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/08/2020
• Supplement Dates Manufacturer Received: 06/19/2020
• Supplement Dates FDA Received: 06/22/2020
• Patient Sequence Number: 1