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

Catalog Number AASME08060

Device Problem Obstruction of Flow (2423)

Patient Problems Ischemia (1942); Obstruction/Occlusion (2422)

Event Date 12/08/2020

Event Type  Injury  

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.(expiry date: 01/2022).

Event Description

It was reported that post stent graft placement, the device allegedly occluded.It was further reported that the right and left femoro-popliteal artery and tibialis posterior artery was stenosed.The occlusion was successfully treated with thromboendarterectomy and a bovine patch plasty.The patient's current status was unknown.

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 sample was not returned for evaluation and image was not provided.Based on the information available the investigation is closed with inconclusive result.A definitive root cause could not be determined based upon the available information.Labeling review: in reviewing the relevant labeling for this product, it was found that the instructions for use sufficiently address the potential risk.Based on the instructions for use complications and adverse events associated with the use of the covera plus vascular covered stent may include the usual complications associated with endovascular stent and covered stent placement and dialysis shunt revisions, which includes restenosis of the target vessel.Regarding pre and post dilation 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" and "post dilate the covered stent with an angioplasty balloon sized appropriately as to ensure complete wall apposition to the reference vessel.Avoid balloon dilation in the healthy, non-stenosed segment of the vessel." (expiry date: 01/2022).Device not returned.

Event Description

It was reported that post placement of a covered stent, the stent allegedly occluded.It was further reported that the right and left femoro-popliteal artery and tibialis posterior artery was stenosed.The occlusion was successfully treated with thromboendarterectomy and a bovine patch plasty.The patient's current status was unknown.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12108326
• MDR Text Key: 259653382
• Report Number: 9681442-2021-00387
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASME08060
• Device Lot Number: ANDV1843
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 56 YR