MAUDE Adverse Event Report: ETHICON INC. MONOCRYL SUTURE 27"(70CM) 2-0 VIO; SUTURE, ABSORBABLE, SYNTHETIC

Catalog Number	Y317H
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fistula (1862)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product complaint #: (b)(4).This report is related to a journal article; therefore, no product will be returned for analysis and the batch history records cannot be reviewed as the lot number has not been provided.Additional information was requested and the following was obtained: how did the suture fail? no further information is available.Did the suture break? if so, did the breakage occur intra or post operatively? no further information is available.Was there any adverse patient consequence? no further information is available.
Event or Problem Description
It was reported via journal article: "myomectomy scar ectopic pregnancy following a cryopreserved embryo transfer," tatsuya ishiguro, kaoru yamawaki, makoto chihara, nobumichi nishikawa, takayuki enomoto, 2018 volume 17, pages 509-513.Case: a (b)(6) woman with a history of a myomectomy visited the department of obstetrics and gynecology, (b)(6) university medical and dental hospital, (b)(6), following 2 years of infertility.Magnetic resonance imaging detected an abnormal endometrial-like pseudo-cavity.A hysterosalpingography also revealed an abnormal accumulation of contrast medium at the myometrial scar site.A transvaginal ultrasound showed a thin myometrium at the lower uterine body.The patient conceived via in vitro fertilization under a luteal phase down- regulation protocol (long protocol) for controlled ovarian stimulation, followed by a cryopreserved embryo transfer during her natural ovulation cycle.After the embryo transfer, the gestational sac was located at the subserosal site of the myomectomy scar.Outcome: an emergent laparoscopic operation was performed and the embryo was removed successfully via laparoscopy under transvaginal ultrasonography.Conclusion: a subserosal uterine pregnancy is a rare form of intramural pregnancy, which is a rare subtype of an ectopic pregnancy, which could occur at the myomectomy site, especially after an embryo transfer.It is believed that this rare ectopic pregnancy resulted from embryo implantation under the serosa through a microsinus tract that was a site of suture failure of the myomectomy scar and was partially affected by the embryo transfer.Clinicians should consider the possibility of an ectopic pregnancy after uterine surgery, including a myomectomy.
Additional Manufacturer Narrative
(b)(4).Additional information was requested and the following was obtained: does the surgeon believe that ethicon products (monocryl suture) involved caused and/or contributed to the post-operative complications described in the article? unknown.Does the surgeon believe there was any deficiency with the ethicon products (monocryl suture) used in this procedure? unknown.No further information will be provided.

• Brand Name: MONOCRYL SUTURE 27"(70CM) 2-0 VIO
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; p.o. box 151, route 22 west; somerville NJ 08876 0151
• MDR Report Key: 8339206
• Report Number: 2210968-2019-78878
• Device Sequence Number: 1774814
• Product Code: GAN
• UDI-Device Identifier: 10705031058767
• UDI-Public: 10705031058767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K960653
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2019

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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: Y317H
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/17/2019
• Supplement Date Received by Manufacturer: 02/20/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 02/21/2019
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention