FDA.reportPublic FDA data

MAUDE MDR 6531095

MDR report key
6531095
Report number
1220948-2017-00031
Event key
0
Event type
3
Date received
2017-04-28
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MR. PRAGYA THIKEY
Address
63 SECOND AVE BURLINGTON MA 01803 US
Phone
781-781-7812
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HYDRO LEMAITRE VALVULOTOMEVALVULOTOMELEMAITRE VASCULAR, INC.MGZ1009-00ELVH1127VR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-2801. O; 2. R

Event Narratives#

N

Patient 1

WE HAVE NOT RECEIVED THE DEVICE FOR EVALUATION SINCE IT WAS DISCARDED BY THE HOSPITAL. HOWEVER, WE HAVE RECEIVED ANOTHER UNOPENED DEVICE FROM THE SAME LOT THAT WAS RETURNED FROM THIS HOSPITAL. WHEN WE EVALUATED THIS DEVICE, WE DID NOT FIND ANY ISSUE. ALL OF THE BLADES WERE ABLE TO INSERT INTO THE RETAINER WHEN THE DEVICE WAS OPENED AND CLOSED MULTIPLE TIMES. AND PASSED ALL OF OUR SPECIFICATIONS. THE COMPLAINT DEVICE WAS TESTED BEFORE THE PROCEDURE BY THE SURGEON AND WAS FOUND TO BE WORKING AS EXPECTED. THE DIFFERENT UNOPENED RETURNED DEVICE THAT WE EVALUATED FROM THE SAME LOT WAS FOUND TO BE WORKING AS EXPECTED AND MEETS OUR SPECIFICATION. IT IS POSSIBLE THAT THE ROOT CAUSE OF THIS DEFECT IS DUE TO ANATOMY OF THE PATIENT'S VEIN OR THE OPERATOR'S MANIPULATION OF THE DEVICE DURING USE. (B)(4) UNITS WERE MANUFACTURED UNDER THIS LOT NUMBER. WE HAVE SOLD ALL OF THE (B)(4) UNITS. OUR REVIEW OF THE LOT HISTORY RECORDS FOR THIS LOT DID NOT FIND ANY DISCREPANCIES EITHER IN THE MANUFACTURING OR PACKAGING PROCESS THAT COULD BE RELATED TO THIS INCIDENT. FURTHER, WE HAVE NOT RECEIVED ANY OTHER COMPLAINTS OF SIMILAR NATURE FOR DEVICES FROM THIS LOT. DEVICE HAS BEEN DISCARDED BY HOSPITAL.

D

Patient 1

DURING IN-SITU BYPASS OF THE SAPHENOUS VEIN, THE VEIN WAS CUT DURING THE FIRST PASSAGE OF THE VALVULOTOME. IT WAS NOT POSSIBLE TO CLOSE THE DEVICE INSIDE THE VEIN AT THE TIME OF REMOVAL, AS A RESULT, IT CUT THE DISTAL 10 CM OF THE VEIN. HOWEVER, DEVICE CLOSED AS EXPECTED OUTSIDE OF THE VEIN. BECAUSE OF THE INJURY TO THE VEIN, THE SURGEON HAD TO PERFORM A COMPOSITE BYPASS SINCE THE REMAINING VEIN WAS NOT LONG ENOUGH.