FDA.reportPublic FDA data

MAUDE MDR 2922226

MDR report key
2922226
Report number
3008867907-2012-00003
Event key
0
Event type
3
Date received
2013-01-15
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
BRUNO MENDEZ
Address
675 WEST KENDALL STREET CAMBRIDGE MA 02142 US
Phone
617-617-6177
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1LEGOO (ENDOVASCULAR OCCLUSION GEL) INJECTIONENDOVASCULAR OCCLUSION GELPLUROMED INC.OBCUNKUNKUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-01-1501. R

Event Narratives#

D

Patient 1

DOPPLER SIGNAL NOT SATISFACTORY (POOR BLOOD FLOW) [DIRECTIONAL DOPPLER FLOW TESTS ABNORMAL]. UNDISSOLVED POLYMER PLUG [DEVICE ISSUE]. CASE DESCRIPTION: LITERATURE-SPONTANEOUS REPORT WAS RECEIVED ON 12/12/2012 FROM AN AUTHOR REGARDING A PATIENT (DEMOGRAPHICS NOT PROVIDED), INITIALS UNKNOWN. THIS REPORT WAS FROM A LITERATURE ARTICLE ENTITLED "A NOVEL REVERSE THERMOSENSITIVE POLYMER TO ARCHIVE TEMPORARY ATRAUMATIC VESSEL OCCLUSION IN INFRA-POPLITEAL BYPASSES". THE PATIENT'S MEDICAL HISTORY WAS SIGNIFICANT FOR SEVERE LEG ISCHEMIA. ON AN UNSPECIFIED DATE, THE PATIENT RECEIVED LEGOO INJECTION, INTRAVASCULARLY LOCALLY, ONE SYRINGE OF 1 ML FOR DISTAL VESSEL CONTROL DURING INFRA-POPLITEAL BYPASS SURGERY IN SEVERE LEG ISCHEMIA. THE LOT NUMBER FOR LEGOO WAS NOT PROVIDED. ON AN UNSPECIFIED DATE, DOPPLER SIGNALS ON THE TARGET VESSEL DISTAL TO THE ANASTOMOSES WERE NOT SATISFACTORY (POOR BLOOD FLOW). THE PATIENT'S INTRA-OPERATIVE ANGIOGRAPHY WAS PERFORMED. THIS SHOWED EVIDENCE OF RUN-OFF OCCLUSION POTENTIALLY DUE TO THE REMAINING INTRA-ARTERIAL POLYMER PLUG. FOGARTYS CATHETER WAS USED TO RETRIEVE THE UNDISSOLVED POLYMER DRUG AND THE PATIENT'S BACK FLOW WAS SUCCESSFULLY RE-ESTABLISHED. THE ACTION TAKEN WITH LEGOO WAS NOT PROVIDED. RELEVANT CONCOMITANT MEDICATIONS WERE NOT PROVIDED. THE REPORTER ASSESSED THE CASUAL RELATIONSHIP BETWEEN LEGOO AND BOTH THE EVENTS AS POSSIBLE.

N

Patient 1

ADDITIONAL INFORMATION WAS RECEIVED ON 12/17/2012 IN THE FORM OF A QA INVESTIGATION. EVALUATION SUMMERY: AS NO LOT NUMBER WAS PROVIDED, A LOT INVESTIGATION COULD NOT BE PERFORMED. MANUFACTURER'S COMMENT: THE BENEFIT-RISK RELATIONSHIP OF LEGOO IS NOT AFFECTED BY THIS REPORT. JOURNAL: EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY. AUTHOR: MANI K, CAMPBELL A, FITZPATRICK J ET AL. TITLE: A NOVEL REVERSE THERMOSENSITIVE POLYMER TO ACHIEVE TEMPORARY ATRAUMATIC VESSEL OCCLUSION IN INFRA-POPLITEAL BYPASSES. YEAR: 2012, PAGES: 1-5.