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

Model Number	AVSM10060
Medical Device Problem Codes	Loss of or Failure to Bond (1068); Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a stent graft placement procedure for a 67 year old patient with a basilic swing point stenosis in an av fistula, the stent allegedly did not deploy at all.It was further reported that the stent was removed.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
A voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 10/2023).
Additional Manufacturer Narrative
A voluntary recall has been initiated for the covera vascular covered stent which was product catalog/lot number specific.Reportedly the covera vascular covered stent has the potential to exhibit deployment issues (i.E., failure to deploy the covered stent) due to slide block bond failures in the device handle.Full or partial failure of the product to deploy is most likely to require percutaneous replacement with existing access.In rare cases, iatrogenic vascular injury may occur as the result of device withdrawal, manipulation, or abrupt/unexpected movements, particularly in the context of difficult or partial stent deployment or mispositioning.Adjunctive endovascular maneuvers may be indicated.There have been no cases where an open surgical procedure has been required.To date, there have been no reported patient injuries associated with deployment issues.As a result of the field action, this event is being reported as a malfunction reportable event.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 stent delivery system of a covered stent was returned for evaluation.The slide block, a force transmitting component was no longer connected to the proximal sheath.The disconnection of the slide block is considered to led to the reported impossibility to deploy the stent which leads to confirmed results.It was reported that an 8fr introducer and a 0.035" guidewire was used during the procedure.Based on evaluation of the sample the inability of an adhesive joint (slide block/tether/diving sheath) to withstand tension force during deployment is confirmed.A definitive root cause could not be determined based upon the available information.Labeling review: the relevant labeling for this product was reviewed.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.With regards to preparation and accessories, 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".Holding and handling of the system throughout deployment was found sufficiently described.H10: d4 (expiration date: 10/2023), g3, h6 (device).Section a through f ¿ the information provided by bd represents all 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 or Problem Description
It was reported that during a stent graft placement procedure for a 67 year old patient with a basilic swing point stenosis in an av fistula, the stent allegedly did not deploy at all.It was further reported that the stent was removed.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: 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 Key: 16519721
• Report Number: 9681442-2023-00074
• Device Sequence Number: 2393875
• Product Code: PFV
• UDI-Device Identifier: 00801741106392
• UDI-Public: (01)00801741106392
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2023

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
• Operator of Device: Health Professional
• Device Model Number: AVSM10060
• Device Catalogue Number: AVSM10060
• Device Lot Number: ANFX4109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/11/2023
• Supplement Date Received by Manufacturer: 06/20/2023
• Initial Report FDA Received Date: 03/10/2023
• Supplement Report FDA Received Date: 06/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 91359
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male