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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS

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W. L. GORE & ASSOCIATES, INC. GORE MOLDING & OCCLUSION BALLOON CATHETER; CATHETER, PERCUTANEOUS Back to Search Results
Model Number MOB37
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Vascular Dissection (3160)
Event Date 07/27/2020
Event Type  Injury  
Event Description
The following was reported to gore: on (b)(6) 2020, this patient underwent endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis.The endoprosthesis was deployed, and touch-up ballooning was performed by a gore® molding and occlusion balloon catheter.A proximal type i endoleak was observed during the procedure, and it was resolved after an additional touch-up ballooning was done.Also a type ii endoleak originating from the hypogastric artery was observed, and the procedure was completed.After returning to the hospital ward, the patient complained of lower back pain or back pain.As the patient had complained of lower back pain prior to the procedure, the physician decided to monitor it.On (b)(6) 2020, computed tomography showed a false lumen of an aortic dissection (type iiib) from the distal aortic arch to the proximal portion of the endoprosthesis (around 1.5 cm distal to the proximal end of the endoprosthesis).There was no complications from the dissection.It seemed that the false lumen was almost occluded.The physician monitored the dissection.The patient will discharge from the hospital within some days.The physician reported as follows: it was possible that some excessive force was used during the touch-up ballooning.I thought the dissection developed either during the procedure or after the procedure.Another physician reported as follows: i believed that the dissection developed either during the procedure or after the procedure.It seemed that the endoprosthesis itself did not cause the dissection since the entry tear was small, the false lumen was almost occluded and there was no specific enlarged portion of the false lumen.Manipulation of a guidewire or pre-existing arterial condition (poor condition of artery was observed around the distal arch) might have involved in the dissection.
 
Manufacturer Narrative
Results code 1: 213: a review of the manufacturing records for the device verified the lot met pre-release specifications conclusion code 1: 22: according to the gore® molding and occlusion balloon catheter instructions for use, excessive inflation volume may result in balloon rupture, embolization, vessel damage, vessel rupture, or patient death.
 
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Brand Name
GORE MOLDING & OCCLUSION BALLOON CATHETER
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
W. L. GORE & ASSOCIATES, INC.
1505 n. fourth street
flagstaff AZ 86004
MDR Report Key10446262
MDR Text Key204175613
Report Number3007284313-2020-01043
Device Sequence Number1
Product Code DQY
UDI-Device Identifier00733132639489
UDI-Public00733132639489
Combination Product (y/n)N
PMA/PMN Number
K172567
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 09/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date03/05/2022
Device Model NumberMOB37
Device Catalogue NumberMOB37
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 07/28/2020
Initial Date FDA Received08/24/2020
Supplement Dates Manufacturer Received09/09/2020
Supplement Dates FDA Received09/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other; Required Intervention;
Patient Age82 YR
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