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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA PLUS VASCULAR COVERED STENT SYSTEM Back to Search Results
Catalog Number AASME07060
Device Problem Migration or Expulsion of Device (1395)
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 covera plus vascular stent system products that are cleared in the us.The product classification code for the covera plus vascular stent system product is identified.The lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has not been returned to the manufacturer for evaluation, however, cd with x-rays was provided.The investigation of the reported malfunction is currently underway.The device is labeled for single use.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model aasme07060 vascular covered stent allegedly experienced migration.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) year old female is 62 kgs.
 
Event Description
This report summarizes one malfunction.A review of the reported information indicated that model aasme07060 vascular covered stent allegedly experienced migration.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 53 year old female is 62 kgs.
 
Manufacturer Narrative
H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the covera plus vascular stent system products that are cleared in the us.The product classification code for the covera plus vascular stent system product is identified in d2.H10: the lot number for the malfunction was provided and a lot history review will be performed.The device for this malfunction has not been returned to the manufacturer for evaluation, however, a cd with x-rays was provided.The investigation is inconclusive for migration.A definitive root cause could not be established.The device is labeled for single use.
 
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Brand Name
COVERA PLUS VASCULAR COVERED STENT SYSTEM
Type of Device
VASCULAR COVERED STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstrasse 6
karlsruhe 76227
GM  76227
MDR Report Key9941287
MDR Text Key187389980
Report Number9681442-2020-00086
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741135873
UDI-Public(01)00801741135873
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Type of Report Initial,Followup
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberAASME07060
Device Lot NumberANDS0704
Date Manufacturer Received06/30/2020
Patient Sequence Number1
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