GEM MICROVASCULAR ANASTOMOTIC COUPLER

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: D9, H3, H6, H11. CORRECTION: D3. H11: THE ACTUAL DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION WAS PERFORMED AND THE PARTIALLY APPROXIMATED RINGS WERE IN A STATE WHERE A FULL ANASTOMOSIS (FULL JOINING OF THE VESSELS) WOULD NOT HAVE BEEN ACHIEVED WITH THE COUPLER DEVICE. THE RINGS APPEARED TO HAVE APPROPRIATE ALIGNMENT AND PINS THAT WOULD MEET THE MATING HOLES ON THE OPPOSING RINGS. WHILE THE RINGS WERE PROPERLY ALIGNED, IT DID NOT APPEAR THAT THEY HAD BEEN FULLY APPROXIMATED TO COMPLETE THE ANASTOMOSIS. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE CONDITION COULD NOT BE DETERMINED; HOWEVER, THERE IS POTENTIAL THAT EXCESS TISSUE WAS EVERTED ONTO THE PINS WHICH WOULD CAUSE A FAILURE TO THE ANASTOMOSIS. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative

D4: UNIQUE IDENTIFIER (UDI) #: THE EXPIRATION DATE (17) IS UNKNOWN; THEREFORE, THE UDI NUMBER ONLY WILL CONTAIN THE DEVICE IDENTIFIER (01) AND LOT NUMBER (10). E1: INITIAL REPORTER ADDRESS:(B)(6). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem

IT WAS REPORTED THE ANASTOMOSIS RING OF A 2.5MM COUPLER COULD NOT BE CLOSED TIGHTLY, AND IT KEPT POPPING OPEN. DURING A RESECTION OF BUCCAL MALIGNANT TUMOR WITH ANTEROLATERAL FEMORAL FREE FLAP REPAIR FOR A BUCCAL FLAP TRANSPLANTATION, THE PHYSICIAN USED A COUPLER TO CLOSE THE ENDS OF THE VEINS. ¿AFTER THE VENOUS WALL WAS IMPALED UPON PINS, ROTATE TO CLOSE THE ANASTOMOSIS DEVICE; HOWEVER, THE ANASTOMOSIS RING COULD NOT BE CLOSED TIGHTLY, AND IT KEPT POPPING OPEN EVEN WITH EXTERNAL ASSISTANCE TO CLAMP IT CLOSED. THERE WAS STILL BLOOD LEAKAGE, AFTER FLUSHING, SO IT WAS EVENTUALLY NORMAL AFTER CUTTING OFF AND REPLACING WITH ANOTHER COUPLER.¿ THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.