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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 SYSTEM
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ANGIOMED GMBH & CO. MEDIZINTECHNIK KG COVERA VASCULAR COVERED STENT SYSTEM Back to Search Results
Catalog Number AASLE07100
Device Problems Break (1069); Positioning Failure (1158); Misfire (2532); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.
 
Event Description
It reported that during the stent placement, the device allegedly had a noise, followed by the detachment of the white sheath from the delivery system with simultaneous breakage of the release mechanism.It was also reported that the stent was partially released.The procedure was completed using another device.There was no reported injury.
 
Event Description
It reported that during the stent placement, the device allegedly had a noise, followed by the detachment of the white sheath from the delivery system with simultaneous breakage of the release mechanism.It was also reported that the stent was partially released.The procedure was completed using another device.There was no reported injury.
 
Manufacturer Narrative
H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot, previously.Based on the information available it is not reasonably suggested that a manufacturing process may have caused or contributed to the reported issue.However, 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 sample was not available, images have not been provided.The alleged issue could not be re produced which led to an inconclusive evaluation result.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.', and 'flush the delivery system through the luer port at the proximal end of the handle with sterile saline until saline drops from the tip of the system'.Under materials required the instructions for use state: '0.035 inch (0.89 mm) guidewire (¿) introducer sheath with appropriate inner diameter and length'; the packaging labels indicate the use of an 8f introducer.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
COVERA VASCULAR COVERED STENT SYSTEM
Type of Device
VASCULAR COVERED STENT
Manufacturer (Section D)
ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
wachhausstr. 6
karlsruhe 76227
GM  76227
MDR Report Key10770716
MDR Text Key214141668
Report Number9681442-2020-20022
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
PMA/PMN Number
P170042
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/27/2021
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 Health Professional
Device Catalogue NumberAASLE07100
Device Lot NumberANEQ2708
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/06/2020
Initial Date FDA Received11/02/2020
Supplement Dates Manufacturer Received05/27/2021
Supplement Dates FDA Received06/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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