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

Catalog Number ISRT-4645L

Device Problem Difficult to Remove (1528)

Patient Problems Edema (1820); Pain (1994); Seroma (2069); Stenosis (2263); Fluid Discharge (2686); Foreign Body In Patient (2687)

Event Date 07/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.An explant evaluation is currently in process.

Event Description

On (b)(6) 2015, a patient was implanted with a gore-tex intering stretch vascular graft for av access.No clamp was made on the graft.A slider sheath was used to place the graft in position.Edema was observed on his left upper arm postoperatively.The physician determined to monitor the patient.On (b)(6) 2015, a stenosis in the vein close to the anastomotic site was observed.On (b)(6) 2015, the patient presented with a pain in the upper arm.A surgical intervention was performed, and a seroma was observed around the graft close to the anastomotic site of the vein.A drain was placed to treat the seroma.On (b)(6) 2015, the persistent growth in edema and serous fluid leakage was observed.A different drain was placed to treat the seroma.On (b)(6) 2015, the drain was removed.On (b)(6) 2015, the graft was partially replaced with another vascular graft, leaving the 2cm portion anastomosed with the vein.It was reported that the vein was conglutinate with the artery underneath, therefore, the graft could not be removed completely.On (b)(6) 2015, the continuous growth in edema was observed.The physician determined to remove the shunt completely, including the remaining portion of the gore-tex vascular graft and a central intravenous catheter was placed instead.The patient tolerated the procedure.

Manufacturer Narrative

The explant evaluation stated that the devices were returned to w.L.Gore & associates for investigation.Submitted in formalin were two gore-tex® intering stretch vascular graft fragments (vgf-1 and vgf-2).Each fragment was approximately 1 cm in length and transected at both poles prior to arrival at w.L.Gore & associates.The lumens of both fragments were widely patent and the luminal surfaces contained a minimal amount of non-adherent red brown tissue.The abluminal surfaces contained multifocal loosely adherent light tan brown tissue.Vgf-2 had a knotted fragment of white suture present at one pole.Histopathological examination of two abluminal tissue specimens from vgf-1 and vgf-2 was performed.Tissue sampled from the abluminal surfaces of the graft segments consisted of a mixture of acute thrombus and seromatous regions.In addition, the graft wall of one of the segments appeared to have been apposed with suture and a bioadhesive was present on the abluminal surface as evidenced by its unique microscopic appearance and eosinophilic inflammatory response.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion the device fragments were examined for material disruptions with the aid of a stereomicroscope.Disruptions identified were not associated with handling or manufacturing process at w.L.Gore and associates.The disruptions are consistent with instruments used as part of a surgical procedure.

• Brand Name: GORE INTERING® 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: sandra whicker ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5012669
• MDR Text Key: 23385937
• Report Number: 2017233-2015-00542
• Device Sequence Number: 1
• Product Code: DSY
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K991683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: ISRT-4645L
• Device Lot Number: 13690684
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2015
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2015
• 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: 62 YR