[3497457]
On (b)(6) 2013, pt as presented to the office for an ultrasound eval of her pregnancy. She was given the diagnosis of a dichorionic-diamniotic triplet pregnancy. This type of pregnancy consists of a singleton fetus in its own amniotic sac with its own placenta and a pair of identical twins within the same amniotic sac that share a placenta. The pt was referred to me by a colleague in (b)(6) for consultation and eval of this rare high risk pregnancy on (b)(6) 2013. The above findings were confirmed and a detailed consultation in regards to this unique triplet pregnancy, specifically with a monochorionic-monoamniotic twin pair, was performed. Management options for this pregnancy were reviewed during the initial consultation and on 2 subsequent visits, (b)(6). The ultrasound eval on (b)(6) identified that triplet (b)(6) had an anomaly to the left hand. Discordant congenital anomalies in these types of twins are not uncommon. During the visit on the (b)(6), the pt and her family indicated that they had elected to proceed with fetoscopic umbilical vessel coagulation and cutting in an attempt to decrease the risk of a twin demise due to umbilical cord entanglement and decrease the risk of neurological injury to the surviving twin if one of them should die as a result of umbilical cord accident. They had elected to coagulate the umbilical vessels of triplet (b)(6), unless at the time of fetoscopy it was noted that triplet (b)(6) had a more severe anomaly. As was counseled extensively about the risks of such a procedure to include the loss of one or both twins, wrong cord coagulation and possibly the loss of all three fetuses due to complications of the procedure. The procedure was performed on (b)(6) 2013, without any known complications. Ultrasound eval at the end of the procedure demonstrated 2 normal fetal heart rates, triplet (b)(6) and what was thought to be triplet (b)(6) at the time. The presumed triplet (b)(6) demonstrated a terminal heart rate as expected from the procedure. The pt tolerated the procedure without any problems and had a follow-up ultrasound eval by my associate the following day. This ultrasound demonstrated 2 viable fetuses and no known complication related to the procedure (rupture of membranes, maternal bleeding, shortened cervical length or chorioamniotic separation). The pt was discharged to home on post-operative day one. On post-operative day number six, she presented to (b)(6) for eval. During an ultrasound performed by myself, i had identified that the surviving monochorionic twin was in fact twin (b)(6) and that twin (b)(6) was the demised fetus. While the intention of the procedure was the cord coagulation of triplet (b)(6), this unforeseen outcome was not as a direct result of the hud device (hud 03120) or any malfunction or misuse of such device. The loss of triplet (b)(6) in this case, is unfortunately a known potential complication of this procedure and is being reported to the fda as an adverse outcome related to the use of a medical device.
Patient Sequence No: 1, Text Type: D, B5