FDA Adverse Event Death Summary report: N

KARL STORZ MINI STRAIGHT-FORWARD TELESCOPE 0°,2 MM

MDR report key: 21375528 · Received February 13, 2025

Report

Report Number
MW5166112
Event Type
Death
Date Received
February 13, 2025
Date of Event
January 14, 2024
Report Date
February 10, 2025
Manufacturer
KARL STORZ SE & CO. / KARL STORZ ENDOSCOPY-AMERICA, INC.
Product Code
HFA
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
OR, US
Reporter Occupation
PHYSICIAN
Health Professional
Yes

Narratives

Description of Event or Problem · 0

(B)(6) IS A 31 YO G5P2002 AT 18W5D (EDD AT (B)(6) 2024) WITH MONOCHORIONIC DIAMNIOTIC TWINS WHO WAS REFERRED FROM OSH FOR TWIN TO TWIN TRANSFUSION SYNDROME. SHE HAD TTTS STAGE III WITH FINDINGS OF TWIN A THE RECIPIENT HAVING REVERSED A-WAVE DV DIAGNOSED AT 17W3 BUT STILL HAD SIGNIFICANT MEMBRANE SEPARATION. TWIN B WAS NOTED TO HAVE INTERMITTENT ABSENT END-DIASTOLIC FLOW (EDF) OF THE UMBILICAL ARTERY (UA). THE CHORIOAMNIOTIC SEPARATION IMPROVED BY 18W5D. SHE UNDERWENT LASER PHOTOCOAGULATION AND AMNIOREDUCTION ON (B)(6) 2023. SHE HAD AN ANTERIOR PLACENTA AND WAS FOUND TO HAVE 17 VASCULAR ANASTOMOSES INCLUDING: 6 SMALL HAIRS,2 SMALL R-D, 2 MEDIUM R-D, 7 MEDIUM D-R. PRE-OPERATIVE FETAL HEART RATES WAS 142 BPM FOR RECIPIENT (TWIN A) AND 164 BPM FOR DONOR (TWINB). PRE-OPERATIVE MITRAL VALVE PROLAPSE (MVP) WAS 14.2CM. POST-OP MVP WAS 14.3CM FOR THE RECIPIENT. POST-OPERATIVE FETAL HEART RATES 142 FOR THE RECIPIENT (TWIN A) AND 148 BPM FOR DONOR (TWINB). PRE-OPERATIVE MIDDLE CEREBRAL ARTERY (MCA) FOR RECIPIENT TWIN A WAS 19.9CM/S AND FOR DONOR TWIN B WAS 14.0 CM/S AND POST-OPERATIVE MCA FOR RECIPIENT TWIN A WAS 19.5CM/S AND DONOR TWIN B WAS 14.0 CM/S. POST-OPERATIVELY, WHEN SHE WAS 22W4D SHE WAS FOUND TO HAVE CERVICAL SHORTENING AND UNDERWENT A RESCUE MCDONALD CERVICAL CERCLAGE. AT 24W ((B)(6) 2024) SHE SPONTANEOUSLY LABORED AND DELIVERED BOTH TWINS. TWIN B FORMER DONOR PASSED ON DOL#7 SECONDARY TO GRADE IV IVH BILATERALLY AND BOWEL PERFORATION. TWIN A FORMER RECIPIENT AND AT THE 1 YEAR FOLLOW UP IS DOING WELL. REFERENCE REPORT: MW5166113.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
902769 KARL STORZ MINI STRAIGHT-FORWARD TELESCOPE 0°,2 MM AMNIOSCOPE, TRANSABDOMINAL (FETOSCOPE) (AND ACCESSORIES) HFA KARL STORZ SE & CO. / KARL STORZ ENDOSCOPY-AMERICA, INC. 11630AA

Patients

Seq Age Sex Outcome Treatment
1 Female Death