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

Model Number	AVSM10100
Medical Device Problem Codes	Break (1069); Misfire (2532)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that during the stent graft placement via the cephalic vein, the delivery system allegedly deployed one centimeter.Furthermore, the healthcare provider continued to roll back the deployment wheel without success, so the delivery system was retracted.Reportedly, a new delivery system was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during the stent graft placement via the cephalic vein, the delivery system allegedly deployed one centimeter.Furthermore, the healthcare provider continued to roll back the deployment wheel without success, so the delivery system was retracted.Reportedly, a new delivery system was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: based on the information available and the investigation performed, there is no indication that the product failed to meet its specification prior to shipment.The lot records have been 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.The review shows that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented, that could have led to the event reported.Investigation summary: based on the investigation of the returned catheter sample it was confirmed that the user could only partially deploy the stent graft.A force transmitting sheath was found fractured at the proximal end which made a successful deployment impossible.An indication for a manufacturing related issue could not be found.As a result of the investigation performed the complaint is confirmed.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the applicable ifu the potential issues were found addressed.The ifu states: 'flush the delivery system through the luer port at the proximal end of the handle with sterile saline until the saline exits the tip of the system', 'pre-dilate the stenosis with a pta balloon catheter of appropriate length and diameter for the lesion to be treated.', and 'examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has been compromised.Do not use the device if any of these conditions are observed.(method, results, conclusion).

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Common Device Name: VASCULAR COVERED STENT GRAFT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 8409945
• Report Number: 9681442-2019-00032
• Device Sequence Number: 11260217
• Product Code: PFV
• UDI-Device Identifier: 00801741106415
• UDI-Public: (01)00801741106415
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: AVSM10100
• Device Catalogue Number: AVSM10100
• Device Lot Number: ANCV1678
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Received by Manufacturer: 02/12/2019
• Supplement Date Received by Manufacturer: 04/25/2019
• Initial Report FDA Received Date: 03/11/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 70