MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE VIABAHN® ENDOPROSTHESIS; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number PAH091502

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Code Available (3191)

Event Date 03/02/2016

Event Type  malfunction  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Evaluation summary: the devices were returned to w.L.Gore & associates for investigation.Submitted unfixed were two gore® viabahn® endoprostheses fragments and two gore® viabahn® endoprostheses.Device fragments had been transected prior to arrival at w.L.Gore & associates.The devices and device fragments arrived in two overlapping configurations.Wire discontinuities were identified for the returned gore® viabahn® endoprostheses fragments and gore® viabahn® endoprostheses.There is a large v-shaped hole in one gore® viabahn® endoprosthesis fragment and one gore® viabahn® endoprosthesis.The lumen of one gore® viabahn® endoprosthesis fragment and one gore® viabahn® endoprosthesis was largely occupied by red-brown soft tissue.The distal lumen of one gore® viabahn® endoprosthesis fragment and one gore® viabahn® endoprosthesis contained a thin layer of red-brown soft tissue extending to larger amounts of similar tissue that partially filled the remaining lumen.The abluminal surfaces were generally devoid of tissue except a minimal, multifocal, thin-layer of red-tan-brown to white-tan soft tissue firmly adhered to all endoprostheses.The abluminal surface of one gore® viabahn® endoprosthesis fragment and one gore® viabahn® endoprosthesis bend also had a circumferential thin layer of tan-brown firmly-adhered soft tissue; wire discontinuities and fragments were observed within the tissue.Histopathological examination of three abluminal and two luminal tissue specimens was performed.The luminal tissue removed from one gore® viabahn® endoprosthesis fragment and one gore® viabahn® endoprosthesis was composed of unorganized fibrin thrombus.The luminal tissue removed from one gore® viabahn® endoprosthesis fragment and one gore® viabahn® endoprosthesis was partially consisted of unorganized fibrin thrombus deposition and partially consisted of acute thrombus which occurred during the explant procedure; small numbers of macrophages were also present.Abluminal tissue varied from an organizing fibrous capsule with calcification to unorganized fibrin likely representing aneurysmal sac contents.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices and device fragments were examined for material disruptions with the aid of a stereomicroscope.The following wear related disruptions were identified: holes in the graft material, fatigue fractures of the stent frame, abrasion of the graft material, and disruption of the bonding and end tape.

Event Description

On (b)(6) 2014, the patient was treated with gore® viabahn® endoprostheses ((b)(4)) to exclude a popliteal aneurysm.Due to gore® viabahn® endoprosthesis migration, another gore® viabahn® endoprosthesis ((b)(4)) was successfully implanted to restore aneurysm exclusion on (b)(6) 2015.On (b)(6) 2016, occlusion of the gore® viabahn® endoprostheses was diagnosed (diagnostic tool not specified).The devices were explanted on (b)(6) 2016 and a bypass procedure was performed.The patient tolerated the procedure.

Manufacturer Narrative

(b)(4).Medwatch # 2017233-2016-00696 were sent in error.Additional received information determined that suspected medical device had no allegation.Therefore this event is not reportable to the fda and therefore the medwatch (and supplementals) will be retracted.

Manufacturer Narrative

(b)(4).Additional device implanted and involved in this event: pah091502/lot12430315 udi: (01)00733132608522(17)170407(21)12626678.Evaluation summary: the devices were returned to w.L.Gore & associates for investigation.Submitted unfixed were two gore®viabahn® endoprostheses fragments (pah091502/lot12430315) and two gore® viabahn® endoprostheses (pah091502/lot12883222 & pah111002/lot12626678).Device fragments had been transected prior to arrival at w.L.Gore & associates.The devices and device fragments arrived in two overlapping configurations: c1: pah091502/lot12883222 and pah091502/lot12430315; c2: pah111002/lot12626678 and pah091502/lot12430315.Wire discontinuities were identified in both configurations.There is a large v-shaped hole in c2.The lumen of c2 was largely occupied by red-brown soft tissue.The distal lumen of c1 contained a thin layer of red-brown soft tissue extending to larger amounts of similar tissue that partially filled the remaining lumen.The abluminal surfaces were generally devoid of tissue except a minimal, multifocal, thin-layer of red-tanbrown to white-tan soft tissue firmly adhered to all endoprostheses.The abluminal surface of the c2 bend also had a circumferential thin layer of tan-brown firmly-adhered soft tissue; wire discontinuities and fragments were observed within the tissue.Histopathological examination of three abluminal and two luminal tissue specimens from c1 and c2 was performed.The luminal tissue removed from c2 was composed of unorganized fibrin thrombus.The luminal tissue removed from c1 partially consisted of unorganized fibrin thrombus deposition and partially consisted of acute thrombus which occurred during the explant procedure; small numbers of macrophages were also present.Abluminal tissue varied from an organizing fibrous capsule with calcification to unorganized fibrin likely representing aneurysmal sac contents.The devices were subjected to an enzymatic digestion process to remove biologic debris.Following digestion all devices and device fragments were examined for material disruptions with the aid of a stereomicroscope.The following wear related disruptions were identified: holes in the graft material, fatigue fractures of the stent frame, abrasion of the graft material, and disruption of the bonding and end tape.

• Brand Name: GORE VIABAHN® ENDOPROSTHESIS
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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: joerg kersten ; 9285263030
• MDR Report Key: 5878156
• MDR Text Key: 52163545
• Report Number: 2017233-2016-00696
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P040037
• 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,Followup
• Report Date: 08/19/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/13/2017
• Device Catalogue Number: PAH091502
• Device Lot Number: 12430315
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/17/2016; 08/19/2016; 08/22/2016
• Date Device Manufactured: 05/14/2014
• 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): Death; Required Intervention
• Patient Age: 81 YR