VWING VASCULAR NEEDLE GUIDE

Additional Manufacturer Narrative

THE PHYSICIAN EXPLAINED THAT THE PATIENT HAD EXPERIENCED PROBLEMS WITH POORLY-HEALING SKIN IN THE PAST ('CRAPPY SKIN'). WHILE THE VWING ITSELF IS NOT LIKELY TO BE THE CAUSE OF THIS PATIENT'S SITE DEHISCENCE, WE CANNOT RULE OUT ANY RELATIONSHIP BETWEEN THE DEVICE AND THE ADVERSE EVENT. WHILE TWO VWING DEVICES WERE EXPLANTED WHEN THE PATIENT'S FISTULA WAS EXCISED, ONLY A SINGLE SITE HAD DEHISCED. BOTH DEVICES WERE THE SAME MODEL: 00145. BUT THEY WERE FROM SEPARATE LOTS. IT IS POSSIBLE THAT THE VWING AT THE SITE THAT NEVER HEALED WAS FROM EITHER LOT 15-0005 OR FROM LOT 15-0029. LOT 15-0005 WAS MANUFACTURED ON 25 JAN 2015, WITH AN EXPIRATION DATE OF JANUARY 2020. LOT 15-0029 WAS MANUFACTURED ON 03 MAR 2015, WITH AN EXPIRATION DATE OF FEBRUARY 2020. INITIALLY SUBMITTED TO FDA ON 05 MARCH 2016 AS 2009273792-2016-00003, INSTEAD OF 3009273792-2016-00003. AMENDED REPORT WITH CORRECT FEI NUMBER (B)(4) SUBMITTED ON 24 MARCH 2016.

Description of Event or Problem

PATIENT (B)(6) WAS IMPLANTED ON (B)(6) 2016 WITH TWO DEVICES. HE PRESENTED TO THE OFFICE WITH WHAT APPEARED TO BE A NECROSED AND INFECTED SURGICAL INCISION AND POCKET EXPOSING HIS VENOUS VWING DEVICE. CANNULATION HAD NEVER BEEN ATTEMPTED BOTH VWINGS WERE WELL ADHERED TO THE VESSEL. DEHISCENCE WAS OBSERVED AT THE VENOUS VWING SITE FOLLOWING IMPLANTATION. ALL CULTURES WERE NEGATIVE. PATIENT (B)(6) HAD A HISTORY OF POOR-HEALING SKIN. THE REASON FOR PLACING VWINGS HAD BEEN TO AVOID A LONG SUPERFICIALIZATION INCISION BECAUSE OF THE PRE-EXISTING SKIN HEALING CONDITION. IMPLANTING SURGEON STATED THAT PATIENT "JUST HAD CRAPPY SKIN." FISTULA WAS ABANDONED AND BOTH VWING DEVICES WERE EXPLANTED ON (B)(6) 2016, AND REPLACED WITH A VEIN GRAFT. THE OPEN VWING SITE WAS LEFT OPEN AND PACKED WITH SALINE DRESSING.