| Class 2 Device Recall GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System |  |
Date Initiated by Firm | September 09, 2020 |
Create Date | October 23, 2020 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-0290-2021 |
Recall Event ID |
86420 |
PMA Number | P040043 |
Product Classification |
System, endovascular graft, aortic aneurysm treatment - Product Code MIH
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Product | GORE TAG CONFORMABLE Thoracic Stent Graft with ACTIVE CONTROL System |
Code Information |
CATALOG NUMBERS TGM212110X* TGM212115X* TGM212120X* TGM262610X* TGM262615X* TGM262620X* TGM282810X* TGM282815X* TGM282820X* TGM313110X* TGM313115X* TGM313120X* TGM343410X* TGM343415X* TGM343420X* TGM373710X* TGM373715X* TGM373720X* TGM404010X* TGM404015X* TGM404020X* TGM454510X* TGM454515X* TGM454520X* TGM262110X* TGM312610X* TGMR313110X* TGMR313115X* TGMR313120X* TGMR312610X* TGMR373710X* TGMR373715X* TGMR373720X* TGMR404010X* TGMR404015X* TGMR404020X* *X is a placeholder for enumeration code: E=EMEA, Australia, New Zealand; J=Japan All lot numbers |
Recalling Firm/ Manufacturer |
W L Gore & Associates, Inc. 3750 W Kiltie Ln Flagstaff AZ 86005-8712
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For Additional Information Contact | 800-528-8763 |
Manufacturer Reason for Recall | Due to secondary deployment fiber being attached to secondary deployment handle, completion of deployment via the deployment line access hatch was not possible |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | On 09/23/2020, the firm sent an "URGENT Medical Device Safety Correction" via First Class Postal (USPS) informing them that all lots of its Thoracic Stent Graft Systems may encounter inability to complete secondary deployment and that the Recalling Firm will be updating it Instruction for Use to include a new Warning:
Secondary deployment events have occurred where the device does not open
to full diameter after Secondary Deployment Handle actuation, and the
deployment line is not accessible via the Deployment Line Access Hatch. If this
event occurs, Gore recommends using the GORE Tri-Lobe Balloon Catheter to
expand the device from trailing end to leading end after complete delivery
system component removal. (Please refer to the GORE Tri-Lobe Balloon
Catheter Instructions for Use for pertinent recommended volume, directions
and warnings.) Ballooning of a non-fully expanded stent graft may lead to
improper placement of the stent graft and/or branch vessel occlusion or
obstruction. Use of an occlusion balloon may lead to device distal displacement
during deployment (windsock effect) and has been observed to lead to branch
vessel occlusion or obstruction.
Customers are instructed to:
-Take note of amendment/reinforcement of Instructions For Use (IFU)
- Please respond to the enclosed acknowledgement
- Please share this letter with others in your hospital or clinic as appropriate
The Recalling Firm is providing physicians with this information so that appropriate risk-related decisions can be made with the patient when considering the Thoracic Stent Graft System. The Recalling Firm maintains its confidence in the safety and efficacy of the device and is not removing the affected products from the market.
There are no actions required for patients already implanted with the Thoracic Stent Graft.
Please contact the Recalling Firm's Customer Service (email: MPDCustomerCare@wlgore.com or by phone at 800-528-8763) with any
questions related to this |
Quantity in Commerce | 13860 units |
Distribution | U.S. - Nationwide
O.U.S. - Australia, Austria, Belgium, Croatia, Cypress, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, Ireland, Israel, Italy, Japan, Lebanon, Luxembourg, Monaco, Netherlands, Norway, New Zealand, Poland, Portugal, Saudi Arabia, Slovenia, South Africa, Spain, Sweden, Switzerland, United Arab Emirates, and United Kingdom |
Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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PMA Database | PMAs with Product Code = MIH
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