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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS

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W.L. GORE & ASSOCIATES GORE® TRI-LOBE BALLOON CATHETER CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number BCL2645
Device Problem Leak/Splash (1354)
Patient Problems Syncope (1610); Death (1802); Hemorrhage, Cerebral (1889); Aortic Dissection (2491)
Event Date 04/25/2012
Event Type  Injury  
Manufacturer Narrative

(b)(4).

 
Event Description

In a review of published literature, these findings were noted: akira katayama, et al. "repair of stent graft-induced retrograde type a aortic dissection after thoracic endovascular aortic repair. " japanese journal of cardiovascular surgery 01/2015; 44(3):133-136. On (b)(6) 2012, a patient presented with dilatation of the distal aortic arch due to chronic type b aortic dissection. She underwent thoracic endovascular aortic repair (tevar) in zone 2 with gore tag thoracic endoprostheses (tgt4015/8861347, tgt3420/9022172) for closure of the entry site at the proximal descending aorta. Angiography showed a proximal type i endoleak; thus touch-up ballooning was performed at the proximal end of the tgt4015 using gore tri-lobe balloon catheter (bcl2645/9882035). Tevar was successfully performed and blood flow in the false lumen stopped. On (b)(6) 2012, the patient was admitted to the hospital with syncope. Ct scan revealed type a aortic dissection, and emergency surgery was performed. The entry was identified at the proximal edge of the proximal device (tgt4015) and ascending aortic replacement was performed with preservation of the devices. No complications were reported after the open surgery. On (b)(6) 2012, the patient was transferred to a rehabilitation hospital. On an unknown date in (b)(6) 2012, the patient expired due to cerebral bleeding. The physician attributed the flare of the tgt4015 and ballooning of the proximal neck to the cause of type a dissection.

 
Manufacturer Narrative

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Brand NameGORE® TRI-LOBE BALLOON CATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
W.L. GORE & ASSOCIATES
flagstaff AZ
Manufacturer (Section G)
MEDICAL DEER VALLEY B/P
24416 n. 19th avenue
phoenix AZ 85085
Manufacturer Contact
marcos ayala
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key5463702
MDR Text Key39147032
Report Number3007284313-2016-00021
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK081799
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/03/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/26/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date11/30/2014
Device Catalogue NumberBCL2645
Device LOT Number9882035
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/23/2011
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 02/26/2016 Patient Sequence Number: 1
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