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

Catalog Number 5F070801C

Device Problem Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

For the reported event, lot number was provided, and lot history review.The return of the sample is pending.The device was labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5f070801c vascular stent system allegedly entrapment of device.This information was received from one source.The event involved a patient with no known impact to the patient.Age, weight and gender of the patient were not provided.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 5f070801c vascular stent system allegedly experienced entrapment of device.This information was received from one source.The malfunction involved a patient with no known impact to the patient.Age, weight and gender of the patient were not provided.

Manufacturer Narrative

H10: the lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was not returned for evaluation.Therefore, the investigation for the reported entrapment of device is inconclusive.A definitive root cause could not be determined based upon available information.The device is labeled for single use.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 that are cleared in the us.The pro code for the lifestent 5f vascular stent system is identified in d2.H10: g4 h11: d3,g1,h6 (method, 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 SYSTEM
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe AZ 76227 ; GM 76227
• MDR Report Key: 10722814
• MDR Text Key: 213701560
• Report Number: 9681442-2020-00219
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00801741120398
• UDI-Public: (01)00801741120398
• 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: 01/06/2021

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: 5F070801C
• Device Lot Number: ANDT3169
• Initial Date Manufacturer Received: 09/30/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 12/31/2020
• Supplement Dates FDA Received: 01/06/2021
• Patient Sequence Number: 1