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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT

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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT Back to Search Results
Model Number AVSM10100
Device Problems Break (1069); Misfire (2532)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2022
Event Type  malfunction  
Event Description
It was reported that during a stent placement procedure, the device allegedly had malfunctioned.There was no reported patient injury.
 
Manufacturer Narrative
Manufacturing review: the lot history records of this lot were reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met the specification prior to shipment.Investigation summary: the delivery system was returned for evaluation in activated condition; the covered stent was found partially deployed; the force transmitting distal stent sheath was broken which indicates high tensile forces were experienced during deployment.It is considered the break of the distal stent sheath led to the impossibility to deploy the stent which leads to confirmed results for break and partial deployment.Based on evaluation of the sample, the investigation is closed with confirmed results for break and partial deployment.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the instructions for use supplied with this product delivery system specific events that could be associated with clinical complications include but are not limited to failure to deploy and high deployment forces.Regarding correct deployment the instructions for use states: "maintain a stationary hold on the white stability sheath during covered stent deployment (¿).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension." based on the instructions for use material required for a procedure using the covera vascular covered stent are (.) 0.035 inch guidewire of appropriate length (.), introducer sheath with appropriate inner diameter.Regarding preparation the instructions for use states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." (expiry date: 06/2024).
 
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Brand Name
COVERA VASCULAR COVERED STENT
Type of Device
VASCULAR COVERED STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
Manufacturer (Section G)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM   76227
Manufacturer Contact
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key16202107
MDR Text Key308748940
Report Number9681442-2022-00399
Device Sequence Number1
Product Code PFV
UDI-Device Identifier00801741106415
UDI-Public(01)00801741106415
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 12/26/2022
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 Health Professional
Device Model NumberAVSM10100
Device Catalogue NumberAVSM10100
Device Lot NumberANGT0777
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/19/2022
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/22/2022
Initial Date FDA Received01/19/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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