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

Catalog Number AASME07100

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Date 02/23/2021

Event Type  Injury  

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 in section d4 has not been cleared in the us but is similar to the covera plus vascular covered stent system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified in d2 and g5.(expiry date: 03/2022).

Event Description

It was reported that nine months post stent placement, the patient allegedly experienced occlusion in the right aie.The patient's current status was unknown.

Event Description

It was reported that nine months post stent placement, the patient allegedly experience occlusion in the right aie.The patient's current status was unknown.

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 system products that are cleared in the us.The pro code and 510 k number for the covera plus vascular covered stent system products are identified in d2 and g4.H10: manufacturing review: a review of manufacturing records was not performed, as additional complaints have not been reported for this lot.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 returned for evaluation.The stent remains implanted.No x-ray images were provided for evaluation.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." h10: d4 (expiry date: 03/2022), g3.H11: h6 (method).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.H3 other text : device not returned.

• Brand Name: COVERA PLUS 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 Key: 11501339
• MDR Text Key: 240271954
• Report Number: 9681442-2021-00155
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: AASME07100
• Device Lot Number: ANEQ2698
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR