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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG LIFESTENT 5F VASCULAR STENT SYSTEM Back to Search Results
Catalog Number 5F070401C
Device Problems Entrapment of Device (1212); Misfire (2532)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
The catalog number identified has not been cleared in the us, but is similar to the lifestent vascular stent system products that are cleared in the us.The product classification code for the lifestent vascular stent system product is identified.The one device belonging to the sole complaint is expected to be returned to bd for evaluation.The company is still investigating the issue at this time.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 5f070401c vascular stent allegedly experienced entrapment of the device.This information was received from one source.The one malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient was 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 vascular stent system products that are cleared in the us.The product classification code for the lifestent vascular stent system product is identified in d2.The lot number was not provided.The device is not returned for evaluation and images were not provided.A definitive root cause for the reported event could not be determined.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 indicated that model 5f070401c vascular stent allegedly experienced entrapment of the device and misfire.This information was received from one source.The one malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient was not provided.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model 5f070401c vascular stent allegedly experienced entrapment of the device and misfire.This information was received from one source.The one malfunction involved one patient with no patient consequences.The age, weight, and gender of the patient was 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 vascular stent system products that are cleared in the us.The product classification code for the lifestent vascular stent system product is identified in d2.The lot number was provided and lot history was reviewed.The device was not returned for evaluation and images were not provided.The investigation was inconclusive for the reported malfunctions.A definitive root cause for the reported event could not be determined.The device was 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.
 
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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 Key9941041
MDR Text Key187388191
Report Number9681442-2020-00084
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00801741120374
UDI-Public(01)00801741120374
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup,Followup
Report Date 06/25/2020
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 Number5F070401C
Device Lot NumberANCW1325
Initial Date Manufacturer Received 03/31/2020
Initial Date FDA Received04/08/2020
Supplement Dates Manufacturer Received06/18/2020
06/18/2020
Supplement Dates FDA Received06/23/2020
06/25/2020
Patient Sequence Number1
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