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

Model Number	AVSM08080
Medical Device Problem Codes	Material Separation (1562); Obstruction of Flow (2423)
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, a manufacturing review could not be performed.The sample was not returned to the manufacturer for evaluation.An x-ray image was provided for review.The company is still investigating the issue at this time.The device is labeled for single use.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 for the covera vascular covered stent system products is identified.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model avsm08080 covera vascular covered stent system allegedly experienced a material separation/dissection on imaging.This information was received from one source.This malfunction involved a patient with no known impact to the patient.The patient's age, sex and weight were unknown.
Additional Manufacturer Narrative
H10: as the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for evaluation; however, four images were provided for review.The investigation is inconclusive for material separation and obstruction of flow.A definitive root cause for the reported event could not be determined.The device is labeled for single use.H10: g4.H11: b5, h6(method, results, conclusion).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 for the covera vascular covered stent system products is identified in d2.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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model avsm08080 covera vascular covered stent system allegedly experienced a material separation and obstruction of flow.This information was received from one source.This malfunction involved a patient with no known impact to the patient.The patient's age, sex and weight were unknown.

• Brand Name: COVERA VASCULAR COVERED STENT SYSTEM
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10271735
• Report Number: 9681442-2020-00153
• Device Sequence Number: 10963404
• Product Code: PFV
• UDI-Device Identifier: 00801741106309
• UDI-Public: (01)00801741106309
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2020

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: No Information
• Device Model Number: AVSM08080
• Device Catalogue Number: AVSM08080
• Device Lot Number: ANDP2665
• Initial Date Received by Manufacturer: 06/30/2020
• Supplement Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1