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

Model Number	AVSM09040
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 12/2022).
Event or Problem Description
It was reported that during a stent placement procedure through the left brachial vein to treat chronic stenosis, the stent allegedly malpositioned and was delivered inaccurately.There was no reported patient injury.
Event or Problem Description
It was reported that during a stent placement procedure through the left brachial vein to treat chronic stenosis, the stent allegedly malpositioned and was delivered inaccurately.There was no reported patient injury.
Additional Manufacturer Narrative
H10: 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 stent delivery system was returned for evaluation.The covered stent was found released and not returned and no defect or deficiency of the device was identified.X-ray images documenting the malposition reported were not provided.Therefore, 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 instruction for use for this product, the potential issue was found addressed.Based on the instruction for use inaccurate deployment, failure to deploy, high deployment forces are delivery system specific events that could be associated with clinical complications.Covered stent deployment procedure was found sufficiently described.E.G., the instruction for use states: "do not touch the distal catheter assembly (i.E.The dark brown catheter segment) during covered stent deployment since this may interfere with covered stent deployment and may lead to misplacement." regarding accessories the instruction for use states that heparinized saline, 0.035 inch guidewire, introducer sheath with appropriate inner diameter and balloon angioplasty catheter for pre and/or post dilation are required materials.In addition, there is a table included in the instruction for use, named "covered stent diameter selection" indicating the recommended oversizing for various covered stent diameters.H10: d4 (expiry date: 12/2022), g3 h11: h6(method, 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
• Common Device Name: 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: 11811262
• Report Number: 9681442-2021-00304
• Device Sequence Number: 14401187
• Product Code: PFV
• UDI-Device Identifier: 00801741106330
• UDI-Public: (01)00801741106330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P170042
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2021

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: AVSM09040
• Device Catalogue Number: AVSM09040
• Device Lot Number: ANEZ3343
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 11/12/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 11/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown