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

Catalog Number AVFLE08060

Device Problem Malposition of Device (2616)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 02/2021).

Event Description

It was reported that during bench-top usability study for stent placement, the stent allegedly malpositioned in the model.There was no patient contact.

Event Description

It was reported that during bench-top usability study for stent placement, the stent allegedly mispositioned in the model.There was no patient contact.

Manufacturer Narrative

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 stent delivery system was returned for evaluation.The covered stent was found released and not returned.No defect or damage of the device was identified.Images demonstrating the malposition were not provided.The device was used in a glass model during benchtop usability study.Malposition may be related to incorrect holding/ handling during the procedure; inaccurate stent sizing or friction coefficient of the covered stent towards glass surface may be contributing factors.Based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the relevant labeling for this product the potential issue was found addressed.The instructions for use closely describe holding and handling of the system throughout the procedure including unpacking and preparation.A table is included for covered stent diameter selection indicating 1-2mm oversizing for a 8mm covered stent.Under materials required accessories are described.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the covera vascular covered stent system products that are cleared in the us.The pro code and 510k number for the covera vascular covered stent system products is identified in d2 and g4.H10: d4 (expiry date: 02/2021), g3.H11: e1, h6 (result, 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.H3 other text : see h10.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Type of Device: VASCULAR STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 11106943
• MDR Text Key: 224865238
• Report Number: 9681442-2020-20139
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/30/2021

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
• Device Operator: Health Professional
• Device Catalogue Number: AVFLE08060
• Device Lot Number: ANDP3930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/28/2020
• Initial Date Manufacturer Received: 12/10/2020
• Initial Date FDA Received: 01/04/2021
• Supplement Dates Manufacturer Received: 10/01/2021
• Supplement Dates FDA Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other