MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS - 3; NIP

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Death (1802)

Event Date 10/22/2017

Event Type  Death  

Manufacturer Narrative

(b)(6).

Event Description

Within the article ¿management of clinically relevant postpancreatectomy hemorrhage (pph) over two decades - a comparative study of 1450 consecutive patients undergoing pancreatic resection¿, published by steffen wolk et al, within the pancreatology, accepted for publication on october 22, 2017, the article results indicate the following: between 1994 and 2014 the occurrence of pph in 115 out of 1450 patients from a prospectively collected database was analyzed.The cohort was divided into two time periods: 1994 - 2009 and 2010 - 2014.The differences between the two groups were analyzed.The objective of the study was the outcome and management of patients after pph and to evaluate the management algorithm for pph in two periods of time.Depending on the origin of hemorrhage, pph can be treated nonsurgically, endoscopically, by relaparotomy or angiographically.In the subgroup with grade c pph in the period from 2010 to 2014, 12 patients were treated with interventional angiography.In this group, only 3 out of 12 patients survived.6 of the 9 deceased patients were treated with stent grafts (gore® viabahn® 5/50 mm in 5 patients, gore® viabahn® 6/50 mm in 1 patient), 2 patients received coil embolization and 1 patient received an unsuccessful intervention.In the subgroup of patients with grade c pph treated with interventional angiography, it should be noted that the main cause for the high case fatality was early stent thrombosis with development of liver abscesses and hepatic failure, and that none of the patients died in severe hemorrhagic shock.Therefore, the authors believe that these patients could have been saved by a more accurate management (e.G.Anticoagulation management).Anticoagulation management depends on interventional treatment.After stent graft placement, combined platelet function inhibition with clopidogrel and aspirin is required to prevent stent graft thrombosis.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS - 3
• Type of Device: NIP
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL ECHO RIDGE B/P; 3250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: barbara ulrich ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8078469
• MDR Text Key: 127394353
• Report Number: 2017233-2018-00699
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P130006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/31/2018

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 61 YR