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

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Vascular System (Circulation), Impaired (2572)

Event Date 10/20/2016

Event Type  Injury  

Manufacturer Narrative

Additional manufacturer narrative: the device was not returned.Consequently, direct product analysis was not possible.Lot number was not available, so manufacturing evaluation could not be conducted.Additional information about this event could not be obtained.As a result, no further investigation is possible.October 20, 2016 is identified in the article as the date the article was accepted, therefore gore is using 10/20/2016 as the date of the incident.The actual incident date is unknown.(b)(4).

Event Description

Accepted article "symptomatic compression of right iliac vein after right iliac artery stent placement" (lindsay young b.S.; jeontaik kwon, m.D.; marianoi arosemena, m.D.; dawn salvatore, m.D.; paul dimuzio, m.D.; babak abai, m.D.; copyright 2016 by the society for vascular surgery, published by elsevier inc.; http//dx.Doi.Org/10.1016/j.Jvsv.2016.10.082) was reviewed.The paper describes a single case report of a patient presenting with symptoms of disabling claudication in the right lower extremity.Two gore® viabahn® endoprosthesis were implanted, an 8x10 was deployed in the right external iliac artery, and an 8x5 was placed in the right common iliac artery.At 2 week follow-up the patient complained of right lower extremity swelling.Right lower extremity edema was noted.Duplex ultrasound imaging ruled out deep vein thrombosis but identified dampening of the right femoral and iliac vein waveforms suggesting the presence of venous compression syndrome.Three weeks later a ct venogram of the abdomen and pelvis showed significant compression of the right common iliac vein as it passed underneath the right common iliac artery.Two 14mmx6cm boston scientific wallstents¿ were placed, one in the right common iliac vein and one in the right external iliac vein at the area of narrowing.Ivus showed resolution of the narrowing.At the 2-week follow-up examination after iliac vein stenting, the patient had significant improvement in his right lower extremity edema.

• Brand Name: GORE® VIABAHN® ENDOPROSTHESIS
• 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: craig bearchell ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6970412
• MDR Text Key: 90029256
• Report Number: 2017233-2017-00548
• Device Sequence Number: 1
• Product Code: PFV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040037
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• 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 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: 60 YR