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

Model Number AVSM07060

Device Problems Misfire (2532); Malposition of Device (2616)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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).

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 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
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 10271344
• MDR Text Key: 199824683
• Report Number: 9681442-2020-00150
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741106248
• UDI-Public: (01)00801741106248
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AVSM07060
• Device Catalogue Number: AVSM07060
• Device Lot Number: ANDY4919
• Date Manufacturer Received: 09/30/2020
• Patient Sequence Number: 1