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

Catalog Number HPT350010A

Device Problem Obstruction of Flow (2423)

Patient Problem No Information (3190)

Event Date 08/01/2014

Event Type  Injury  

Event Description

A gore® propaten® vascular graft was implanted in a pediatric shunt configuration.During the procedure, the physician reported using a large aortic cross clamp with teeth in the middle of the graft.When the patient was in recovery room and the heparin drip was stopped, the graft clotted.The graft was removed and another shunt was implanted.

Manufacturer Narrative

A lot number was not reported for this event.A review of the manufacturing paperwork could not be performed.The use of a large aortic cross clamp with teeth in the middle of the graft may have contributed to the event.Per instructions for use, "when applying clamps, care should be taken to avoid mechanical damage to, or disruption of, the graft.Use the appropriate atraumatic or guarded (for example, rubber shod) clamps.Avoid repeated, localized clamping or excessive clamping on any section of the graft.".

Manufacturer Narrative

Catalog # hpt350010a.

• 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: roger smith ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 4132772
• MDR Text Key: 4790439
• Report Number: 2017233-2014-00510
• 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,Followup
• Report Date: 10/09/2014

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 Catalogue Number: HPT350010A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/09/2014
• 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): Required Intervention