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

Model Number	AVSM09060
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Misfire (2532)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2020
Type of Reportable Event	Malfunction
Additional 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: 03/2022).
Event or Problem Description
It was reported that during a stent placement in upper arm, the stent was allegedly failed to deploy.The procedure was completed using another device.There was no reported patient injury.
Additional 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 physical sample was returned for evaluation.Based on the provide sample, the system was found activated and the covered stent was found partially deployed.Based on the sample investigation, a catheter segment inside the grip was found broken.Potential factors which may have caused or contributed to the reported issue have been considered.Therefore, previous investigations of similar complaints have been reviewed.Partial deployment and detachment of the components were considered the consequence of high release force which may be related to difficult patient condition or challenging placement site.Inappropriate accessories, insufficient pre dilation or incorrect holding/handling may lead to friction increase and may be contributing factors.In this case, the lesion was pre dilated, and the vessel was not tortuous and/ or calcified.A system compatible 8f introducer was in use but the guidewire size was not known.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable labeling potential issues were found addressed.The instructions for use closely describe the way of holding and handling the system, and how the correctly deploy the stent graft; in particular the instructions for use state : 'slowly and carefully activate the covered stent release mechanism by rotating the large wheel on the top of the handle backwards.' under materials required the instructions for use state: 'introducer sheath with appropriate inner diameter', and the packaging labels indicated a minimum introducer size of 8f.In regards to pta the ifu state: 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.' h10: d4 (expiry date: 03/2022).H11: section a through f ¿ the information provide 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.H3 other text : see h10.
Event or Problem Description
It was reported that during a stent placement in upper arm, the stent was allegedly failure to deploy.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstr. 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10893337
• Report Number: 9681442-2020-20042
• Device Sequence Number: 2895085
• Product Code: PFV
• UDI-Device Identifier: 00801741106347
• UDI-Public: (01)00801741106347
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: AVSM09060
• Device Catalogue Number: AVSM09060
• Device Lot Number: ANEQ4000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 04/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR