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

Device Problem Positioning Problem (3009)

Patient Problem Fistula (1862)

Event Date 03/06/2015

Event Type  Injury  

Event Description

On (b)(6) 2015, an gore® acuseal vascular graft was implanted in conjunction with an hero® graft.The gore® acuseal vascular graft was sewn onto the hero® graft.On (b)(4) 2015, an attempt to cannulate the gore® acuseal vascular graft for the first time was unsuccessful.Reportedly, they could not find a thrill.As reported, the patient had already failed 3 fistulas and the physician thought the patient may have a clotting disorder but could not confirm.

Manufacturer Narrative

No testing methods performed.No results available since no evaluation performed.

Manufacturer Narrative

Date of event - (b)(6) 2015.Relevant tests/laboratory data, including dates - (ni) blank.

Manufacturer Narrative

(b)(4).On (b)(6) 2015, an acuseal graft was implanted in conjunction with an hero graft.The acuseal graft was sewn onto the hero graft.On (b)(6) 2015, an attempt to cannulate the acuseal graft for the first time was unsuccessful.Reportedly, they could not find a thrill.As reported, the patient had already failed 3 fistulas and the physician thought this may be the patient¿s last option.The physician had low expectations that the graft would work and thought the patient may have a clotting disorder but could not confirm.

• Brand Name: GORE® ACUSEAL 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: 4653501
• MDR Text Key: 22036050
• Report Number: 2017233-2015-00206
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• 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,Followup
• Report Date: 07/10/2015

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
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/02/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 06/11/2015; 07/10/2015
• 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): Other
• Patient Age: 47 YR