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

Model Number	AVSM07060
Medical Device Problem Codes	Misfire (2532); Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided; therefore, a lot history review will be performed.The return of the sample is pending.The investigation of the reported event is currently underway.The device was labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model avsm07060 covera vascular covered stent allegedly experienced malposition.This information was received from one source.This malfunction involved one patient with no consequences.The weight of (b)(6) male is (b)(6).
Additional Manufacturer Narrative
H10: the lot number was provided; therefore, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.The investigation was inconclusive for the reported misfire.A definite root cause for the reported event could not be determined.The device is labeled for single use.H11: d4 (udi no), h6 (device, method, results and 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.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model avsm07060 covera vascular covered stent allegedly experienced malposition.This information was received from one source.This malfunction involved one patient with no consequences.The weight of 69 year old male is 73 kgs.

• Brand Name: COVERA VASCULAR COVERED STENT
• Common Device Name: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10271344
• Report Number: 9681442-2020-00150
• Device Sequence Number: 10963403
• Product Code: PFV
• UDI-Device Identifier: 00801741106248
• UDI-Public: (01)00801741106248
• 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): 10/08/2020

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: AVSM07060
• Device Catalogue Number: AVSM07060
• Device Lot Number: ANDY4919
• 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: 10/08/2020
• Patient Sequence Number: 1