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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC

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BOSTON SCIENTIFIC CORPORATION FLEXIMA APDL; TUBE, DRAINAGE, SUPRAPUBIC Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abscess (1690); Fever (1858)
Event Date 07/04/2020
Event Type  Injury  
Manufacturer Narrative
Gulsah bayram ilikan, llkay akmangit.Percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprotesis applications in malign biliary obstructions.J contemp med 2021;11(1):97-103.
 
Event Description
It was reported via journal article that patient complications occurred.Abstract: the study aimed to present the effectiveness of percutaneous transhepatic cholangiography, percutaneous biliary drainage and metallic endoprosthesis applications in patients with inoperable biliary obstructions.Pbd was performed after percutaneous transhepatic cholangiography (ptc) in 44 inoperable patients with malignant obstructive jaundice who were referred to our interventional radiology unit over a period of 3 years.The ages of the patients to whom we applied pbd ranged between 37 and 80 (mean 63) and 29 were male (65.9%) and 15 were female (34.1%).The hilar observation grading of all patients was done according to the bismuth typing.Accordingly, 4 of the patients were type i (9%), 4 were type ii (9%), 11 were type iiia (25%), 17 were type iiib (39%), 8 were type iv (%).18).29 of the patients (65.9%) had previously been operated before due to their primaries.Six cases (13.6%) underwent only external biliary drainage (ebd), 27 cases (61.4%) underwent only internal-external biliary drainage (iebd), and 11 cases (25%) underwent metallic stent after iebd.Ptc and ebd were applied to one of the patients first from the left, and in the next session, iebd was applied from the right.Iabd catheters were placed in both right and left intrahepatic bile ducts in two patients.Biliary drainage was applied to all other patients (93.2%) by entering from the right.Spontaneously expandable metallic stent was placed in 11 (25%) of the patients underwent iebd, after 1-34 days (average 6 days).The distribution of the diagnoses of the patients according to the procedure is summarized in table 1.Results: the procedure was successfully completed by providing biliary drainage in all 44 patients who underwent biliary drainage (technical success 100%).The patients were followed for the shortest 2 days and the longest 670 days (median 23 days).In the first 2 weeks after pbd, improvement in the general condition and a decrease in complaints such as weakness and itching of 38 patients (86%) were found.In 6 patients (13.6%) whose distal stenosis could not be passed in the first session, because their relatives did not want a second procedure, the catheter was left to external drainage only and it was followed.External and internal drainage was performed in the same session in 30 (80%) of 38 patients who underwent iebd.In 8 of the patients (20%), since the distal of the stenosis could not be passed, an 8 f external drainage catheter was placed first, it was waited for the duration varying between 4-55 days to resolve the edema in the stenosis localization.After the regression of the edema, internal drainage was started.The catheters of two of the patients in our follow-up; were replaced on day 124 of one patient, the other on day 259 of another, with a new one.The catheters of two patients were dislocated within the first day after the procedure and were corrected with a guide wire.Stents were implanted in the right lobe using the right transhepatic approach in all patients and in all patients without periampullary tumor, the distal end of the stents was left at the suprapapillary level in order to minimize the risk of possible ascending cholangitis (figures 2a, 2b).In one patient with a periampullary tumor in which the stent was placed, the stent was left before the papillae when the stenosis could not be overcome.Balloon dilatation was performed in 2 patients, one of which was a periampullary tumor, because the stent width did not reach a sufficient diameter (diameter less than 8mm).Ercp guided stent was placed in 3 patients with iebd at an external center.Patient status: complications were observed in 10 patients (22.7%) during follow-up.Fever was observed in 6 patients (13.7%) the day after the procedure in the early period and resolved within 24 hours following antibiotic treatment.It was observed that the liver enzymes of the patients did not increase compared to the pre-procedure values and the image was not interpreted as cholangitis.Abscess occurred within the first week after the procedure in 2 patients (4.5%) who also had an operation history, and it was recorded as a procedure complication.None of the patients had hematoma, major bleeding, hematobilia, hepatic arteriovenous fistula, hemothorax, sepsis, peritonitis after bile leakage, contrast allergy, or procedural death, which were reported as complications of pbd procedure in the literature.In the long term, obstruction developed in the stent of 2 patients (18.2%).While external drainage was provided again in one of the patients, the other died due to the deterioration of his general condition.The mean tb, alp, alt, ast, ggt values obtained before and after drainage in all patients were compared with the significance test of the difference between the two partners, and a significant decrease was found in the post-procedure values (paired samples t test, p less than 0.05).(table 2).While no significant tb decrease was detected in the first week in patients who were applied only ebd, the decrease in tb detected in the late period was significant (p=0.006) (table 3).In patients who underwent iebd plus or mimus stent, a significant decrease in tb was found both in the early (p=0.000) and late periods (p=0.005) (table 4).During the follow-up, 35 (79.5%) of the patients died due to terminal malignant diseases.Seven patients (15.9%) are still living with their catheters or stents, and 2 patients (4.5%) are out of follow-up.Average lifetimes according to the type of performed transaction were found to be 218 (se, 52) days in cases with ebd, 192 (se, 41) days in cases with iebd alone, and 182 (se, 103) days in cases with stent implantation.When compared according to the log-rang test, no significant difference was found between the groups (p greater than 0.05).According to the statistical power analysis, 44 observations, 0.05 significance level and cohen d value as 0.7, test strength for two identical duplex tests was calculated as 0.90008.
 
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Brand Name
FLEXIMA APDL
Type of Device
TUBE, DRAINAGE, SUPRAPUBIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC DE COSTA RICA S.R.L.
2546 calle primera
alajuela
CS  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15085613
MDR Text Key296402192
Report Number2134265-2022-08071
Device Sequence Number1
Product Code FFA
Combination Product (y/n)N
Reporter Country CodeTU
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 07/22/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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