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

Catalog Number UNK COVERA

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Unspecified Infection (1930); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: papadoulas, s.I., & kakkos, s.K.(2019).A stent graft visualised through an infected haemodialysis graft pseudoaneurysm.European journal of vascular and endovascular surgery, 57(1), 149.Doi: 10.1016/j.Ejvs.2018.10.005.[(b)(4)].

Event Description

It was reported in an article from the journal of european society for vascular surgery titled "a stent graft visualised through an infected haemodialysis graft pseudoaneurysm" that two weeks after the placement of the covered stent for the two needlestick pseudoaneurysms of a brachio-axillary ptfe haemodialysis graft repair, the patient presented with infection of the largest (5 cm) pseudoaneurysm.Intra-operatively the pseudoaneurysm was incised with drainage of the pus; the aneurysm sac, part of the graft, and stent graft were excised.Culture results were normal and the wound healed by secondary intention, after a six weeks vancomycin/ciprofloxacin antibiotic course.

Event Description

It was reported in an article from the journal of european society for vascular surgery titled "a stent graft visualised through an infected haemodialysis graft pseudoaneurysm" that two weeks after the placement of the covered stent for the two needlestick pseudoaneurysms of a brachio-axillary ptfe haemodialysis graft repair, the patient presented with infection of the largest (5 cm) pseudoaneurysm.Intra-operatively the pseudoaneurysm was incised with drainage of the pus; the aneurysm sac, part of the graft, and stent graft were excised.Culture results were normal and the wound healed by secondary intention, after a six weeks vancomycin/ciprofloxacin antibiotic course.

Manufacturer Narrative

H10: manufacturer review: a lot history record could not be completed as the lot number was not provided.Investigation summary: based on the information available the investigation is closed with inconclusive result.A definite root cause for the reported event could not be determined.Labeling review: in reviewing the current labeling it was found that the instructions for use (ifu) sufficiently address this potential risk.Journal article citation: papadoulas, s.I., & kakkos, s.K.(2019).A stent graft visualised through an infected haemodialysis graft pseudoaneurysm.European journal of vascular and endovascular surgery, 57(1), 149.Doi: 10.1016/j.Ejvs.2018.10.005.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.

• 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: 9284804
• MDR Text Key: 165247828
• Report Number: 9681442-2019-00209
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• PMA/PMN Number: P170042
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK COVERA
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR