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

Catalog Number AASME09060

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2018

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a manufacturing review was 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 instruction for use (ifu) is adequate for the reported device/patient 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.( expiration date: 07/2020).The information provided by bard 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 bard.

Event Description

It was reported during stent implantation, the stent was allegedly forty millimeters instead of sixty millimeters.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the lot records have been 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.The review showed that no remarkable incidents occurred during the manufacturing process.No relevant manufacturing process changes were implemented that could have led to the event reported.Based on the lot history records, stents with correct dimension were used during the assembly of this lot.Investigation summary: as no product sample and no x-ray images were provided the reported problem could not be reproduced.The investigation will be closed with inconclusive result.Based on the information available the investigation is closed with inconclusive result.A definite root cause could not be determined.Label review: in reviewing the relevant labeling it was found that the instructions for use (ifu) sufficiently address the deployment procedure of the covered stent.The ifu states: "prior to covered stent deployment, unlock the red safety lock (figure 7) by pressing it down and pulling it back towards the end of the grip from the locked position into the unlocked position.Ensure that the red safety lock is completely retracted and that the symbol for the unlocked position is fully visible.With your free hand, maintain a stationary hold on the white stability sheath during covered stent deployment and adjust for placement accuracy if necessary (figure 8).Hold the white stability sheath as close as possible to the introducer without touching the dark brown moving catheter of the distal catheter assembly.Maintain the remainder of the white stability sheath (.) relaxed and avoid tension.(.).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." 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

It was reported that a 9x60 mm stent was found to have a length of 40 mm instead of 60 mm, as referenced on the label.This was verified by the physician, when the stent was compared with another 9x60 mm stent.The additional stent placement was required as the stent was too short after placement.There was no reported patient injury, the patient is doing fine.

• Brand Name: COVERA PLUS VASCULAR COVERED STENT SYSTEM
• Type of Device: VASCULAR COVERED STENT
• Manufacturer (Section D): ANGIOMED GMBH & CO. MEDIZINTECHNIK KG; wachhausstrasse 6; karlsruhe 76227 ; GM 76227
• MDR Report Key: 7906343
• MDR Text Key: 121712800
• Report Number: 9681442-2018-00176
• Device Sequence Number: 1
• Product Code: PFV
• UDI-Device Identifier: 00801741135972
• UDI-Public: (01)00801741135972
• 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
• Type of Report: Initial,Followup
• Report Date: 09/17/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: AASME09060
• Device Lot Number: ANCU2721
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/10/2018
• Initial Date FDA Received: 09/25/2018
• Supplement Dates Manufacturer Received: 09/17/2019
• Supplement Dates FDA Received: 09/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1