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

Catalog Number AASLE07080

Device Problems Loss of or Failure to Bond (1068); Positioning Failure (1158)

Patient Problem Insufficient Information (4580)

Event Date 11/17/2021

Event Type  Death  

Event Description

It was reported that during an stent graft placement procedure via superior mesenteric artery, the stent allegedly failed to deploy.The procedure was completed using another device.It was further reported that the patient was expired.It is unknown if at this time if death was related to the device.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records 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.The catalog number identified has not been cleared in the us but is similar to the covera plus vascular covered stent products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified.(expiry date: 04/2023).

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 covered stent products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent products are identified in d2 and g4.H10: 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, and it was confirmed that the covered stent could not be deployed.The slide block inside the delivery system - a force transmitting component - was no longer connected to the proximal sheath.Based on the condition of the sample it is concluded that the slide block getting disconnected, led to the reported impossibility to deploy the stent.The intended use of the device represents an off-label use.The investigation is confirmed for both failure to deploy and loss of or failure to bond.A definitive root cause for the reported issue could not be determined based on the available information.Labeling review: in reviewing the relevant labeling for this product, the potential issue was found addressed.Based on the ifu 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 the precautions prior to deployment, the ifu state: 'if unusual resistance is met during covered stent system introduction, the system should be removed and another covered stent system should be used.Regarding correct deployment the ifu 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 deep brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension.Retraction of the distal catheter and deployment of the covered stent is initiated by rotating the large wheel on the handle.' regarding preparation and accessories, the ifu states: "pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated." and "0.035-inch (0.89 mm) guidewire of appropriate length (¿) introducer sheath with appropriate inner diameter and length." the intended use of the device for stent placement in the superior mesenteric artery represents an off-label use.Based on the ifu supplied with this product the covera¿ plus vascular covered stent is indicated for the treatment of stenoses in the upper extremity venous outflow and for the treatment of atherosclerotic lesions in iliac and femoral arteries.H10: d4 (expiry date: 04/2023), b5, g2, g3, h6 (device).H11: b2, g1, h6 (methods, results, conclusion).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.

Event Description

It was reported that during a stent graft placement procedure via superior mesenteric artery, the stent allegedly failed to deploy.The procedure was completed using another device.It was further reported that the patient was expired a couple of hours after the procedure due to hemorrhagic shock.It is unknown if at this time if death was related to the device.

• Brand Name: COVERA PLUS 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 Key: 13818933
• MDR Text Key: 287521217
• Report Number: 9681442-2022-00078
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741136139
• UDI-Public: (01)00801741136139
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASLE07080
• Device Lot Number: ANFR2505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/08/2022
• 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 Number: 1
• Patient Outcome(s): Death