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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 AVSM08080
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/22/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.However, two photos of the device were provided and are pending review.The lot number was not provided, a review of the device history records has not been performed.The device has been returned for evaluation.The investigation is currently underway.The information provided by bard 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 bard.
 
Event Description
It was reported that during a covered stent placement procedure of the left upper extremities in an a/v graft with an ipsilateral approach of a tortuous vessel, the outer catheter sheath allegedly became completely detached from the handle upon advancement.The system was reportedly retracted with no issues.Reportedly, another covered stent was used to complete the procedure.There was no reported patient injury.
 
Manufacturer Narrative
The lot history records have been 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.No manufacturing anomalies or changes which may have caused or contributed to the reported event have been identified.No additional complaint has been previously reported for this lot number.Based on the returned sample and the provided photos a detachment of the proximal stability sheath from the kink protection could be confirmed.It was concluded that increased tension force must have been present during the treatment which led detachment of the stability sheath from the kink protection.No indication for a manufacturing related issue could be found.Based on the evaluation of the returned sample and the provided information a definite root cause for this issue could not be determined.In reviewing the currently valid labeling for this product it was found that the instructions for use (ifu) sufficiently address this potential risk.The ifu states: "examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed." after further review of the details provided by the complainant, it was identified that the fda rn number was incorrect and the correct fda rn number is (b)(4).This number will not be changed on the emdr so that this report will remain connected and identify that the event was reported to the fda in a timely manner.
 
Event Description
It was reported that during a covered stent placement procedure of the left upper extremities in an a/v graft with an ipsilateral approach of a tortuous vessel, the outer catheter sheath allegedly became completely detached from the handle upon advancement.The system was reportedly retracted with no issues.Reportedly, another covered stent was used to complete the procedure.There was no reported patient injury.
 
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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 Key7885592
MDR Text Key120561493
Report Number2020394-2018-01726
Device Sequence Number1
Product Code PFV
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAVSM08080
Device Lot NumberANCT4138
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/04/2018
Date Manufacturer Received10/31/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight55
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