MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE PROPATEN® VASCULAR GRAFT; PROSTHESIS, VASCULAR GRAFT

Catalog Number H060040A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Edema (1820); Erythema (1840); Hypersensitivity/Allergic reaction (1907); Inflammation (1932); Pain (1994)

Event Date 07/28/2014

Event Type  Injury  

Event Description

The surgeon reported to gore that the patient experienced inflammation on the skin surface above the gore propaten® vascular graft.The surgeon communicated he believes the inflammation is related to the luminal surface coating of the graft.Additional information received by gore reported the following: "pt developed severe hypersensitivity reaction 7-10 days after placement of right forearm gore propaten® vascular graft.Symptoms included significant erythema, edema, and tenderness along the tunneled tract.Unfortunately he [the patient] also developed steal syndrome and subsequent right hand ischemia unrelated to the reaction.Therefore we opted to excise the graft.Pt had immediate improvement in hypersensitivity reaction.".

Manufacturer Narrative

Review of the manufacturing and sterilization records verified that the lot met release requirements.The device was not returned.Consequently, a direct product analysis was not possible.Based on the investigation, we are unable to determine the exact cause(s) of this event.

• Brand Name: GORE PROPATEN® VASCULAR GRAFT
• Type of Device: PROSTHESIS, VASCULAR GRAFT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WEST B/P; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer Contact: craig bearchell ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4024739
• MDR Text Key: 4727969
• Report Number: 2017233-2014-00429
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062161
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2017
• Device Catalogue Number: H060040A
• Device Lot Number: 4275012PP028
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2013
• 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): Required Intervention
• Patient Age: 35 YR
• Patient Weight: 61