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

Catalog Number 5F060601C

Device Problems Difficult to Remove (1528); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided for the reported malfunction; therefore, a lot history review is currently being performed.The sample was returned to bd for evaluation.The company is still investigating the issue at this time.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.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5f060601c vascular stent allegedly experienced a positioning issue and difficult to remove.This information was received from one source.This malfunction involved a patient with no reported consequences.The patient's age, weight, and gender were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5f060601c vascular stent allegedly experienced a positioning issue and difficult to remove.This information was received from one source.This malfunction involved a patient with no reported consequences.The patient's age, weight, and gender were not provided.

Manufacturer Narrative

H10: 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.The device is labeled for single use.The lot number was provided for the reported malfunction; therefore, a lot history review was performed.The device was returned for evaluation; the investigation is inconclusive for the reported difficult to remove and positioning issues.Based upon the available information, a definitive root cause is unknown.The device is labeled for single use.H10: g4.H11: h6(results, 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.

• 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: 9570366
• MDR Text Key: 179113471
• Report Number: 9681442-2020-00003
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741119989
• UDI-Public: (01)00801741119989
• 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: 03/30/2020

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: 5F060601C
• Device Lot Number: ANCV0514
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 03/27/2020
• Supplement Dates FDA Received: 04/01/2020
• Patient Sequence Number: 1