MAUDE Adverse Event Report: COOK IRELAND LTD ZIMMON BILIARY STENT; FGE CATHETER, BILIARY, DIAGNOSTIC

Catalog Number ZSO-7-15

Device Problems Off-Label Use (1494); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/03/2011

Event Type  malfunction  

Event Description

"lee t h.Et al., 2011, zimmon biliary stent, outcomes of endoscopic transpapillary gallbladder stenting for symptomatic gallbladder diseases: a multicenter prospective follow-up study.Following an overnight fast, all patients underwent endoscopic retrograde cholangiopancreatography (ercp) with a standard duodenoscope (tjf 240; olympus optical co., ltd., tokyo, japan) in the prone or lateral position, after sedation with intravenous midazolam (0.05 mg/kg) and/or propofol (0.5 mg/kg).Prophylactic antibiotics and analgesics were permitted (100 %).Access to the cystic duct and gallbladder was attempted with one of the following guide wires: a 0.035-inch-diameter, 450-cm-long hydrophilic jagwire catheter tip (boston scientific corp., natick, massachusetts, usa); a 0.035-inch hydrophilic radifocus guide wire (stiff type, terumo, tokyo, japan); or a 0.035-inch-diameter, 480-cm-long, hydrophilic, slip-coat tip tracer guide wire (wilson-cook medical inc., winston-salem, north carolina, usa), through cannulating catheters, including the standard catheter, pull-sphincterotome, or rotating sphincterotome (autotome rx; boston scientific).After successful bile duct cannulation, the guide wire-preloaded catheter was advanced to negotiate the cystic duct.The distance between the gallbladder and the duodenum was measured by pulling the catheter conveniently outside the endoscope until it traversed from the gallbladder to the major duodenal papilla.Based on the measured distance, a 7-fr, 7¿15-cm-long double-pigtail polyethylene plastic stent (zimmon; wilson-cook medical) was placed between the gallbladder and the duodenum (fig.1).Endoscopic sphincterotomy (est) and/or endoscopic papillary balloon dilation (epbd) were performed in patients with common bile duct (cbd) stones, suspected choledocholithiasis, or cbd dilatation (>8mm with gallbladder in situ) with abnormal liver biochemical tests, including bilirubin.Etgs was successful in 23 (79.3 %) of the 29 candidates.Procedure-related adverse events in the etgs group were mild pancreatitis (2/23, 8.7 %) and cholestasis (2/23, 8.7 %).Mild post-ercp pancreatitis developed in two patients who did not undergo est or epbd (p = 0.012).Est and/or epbd were performed in 20 patients (87 %) who had cbd stones (n = 10), suspected choledocholithiasis (n = 4), and cbd dilatation (n = 6).Three patients who did not undergo est or epbd had calculous cholecystitis (n = 2) and biliary pain (n = 1) with normal cbd and liver chemistry.Cholestatic liver dysfunction with no evidence of cholangitis developed in two patients who did not undergo est or epbd.However, all of these resolved with conservative management.During the follow-up period (median 586, range 11¿1403 days), three patients were excluded due to unrelated death: complication of lung cancer (11 days), liver transplantation (303 days), and stent removal by demand of the patient (850 days).Delayed adverse events developed in four patients (20 %), including distal migration (n = 2), cholangitis (n = 1), and recurrent biliary pain (n = 1).Spontaneous distal migration occurred in two patients, who had undergone sphincterotomy (p = 1.00), at 7 months after etgs.One patient continued to have recurrent biliary pain without stones at 12 months after etgs, and another patient, who had not undergone sphincterotomy, developed cholangitis with choledocholithiasis 19 months after etgs.Migrated or complicated stents were removed without stent exchange, and patients remained under outpatient observation without adverse events.In total, clinically significant adverse events developed in three patients (two distal migration, one recurrent biliary pain) in the est or epbd group and three patients (two mild pancreatitis and one cholangitis) in the no est or epbd group (p < 0.05).However, there was no difference in event-free interval between patients who underwent est or epbd and those who did not (p = 0.397).The remaining 16 patients were followed for more than 12 months, and nine of these were followed for more than 24 months without significant adverse events.This file was opened to capture user error and off label use- scheduled stent exchange or removal was not performed in our study.As per ifu0045-7, 'the device should not be left indwelling for more than three months.' (n=23).It can be noted that the zimmon biliary stents were used off-label as the stent was used to stent the gallbladder.As per ifu0045-7, 'this device is used to drain obstructed biliary ducts.' (n=13).

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Manufacturer Narrative

Device evaluation: 1 x zso-7-15 device of lot number unknown was not returned to cirl for evaluation.With the information provided, a document-based investigation was conducted.File related to (b)(4)(report reference number 3001845648-2022-00313).Lab evaluation: n/a document review: as the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution, all zso-7-15 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0045) of the device states the following: ¿intended use: this device is used to drain obstructed biliary ducts¿.¿precautions: ¿this device should not be left indwelling for more than three months or as directed by a physician.Periodic evaluation is recommended.There is evidence to suggest the user did not follow the ifu.Image review: n/a root cause review: a definitive root cause of user error was identified from the available information.As per the ifu, cook zimmon biliary stent devices are intended to be left indwelling for a maximum period of 3 months.As per the information reported in this file, the complaint device was left indwelling more than three months, "scheduled stent exchange or removal was not performed in our study".Summary: the complaint is confirmed based on customer testimony.According to the initial report, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• Brand Name: ZIMMON BILIARY STENT
• Type of Device: FGE CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 14547531
• MDR Text Key: 300808507
• Report Number: 3001845648-2022-00312
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• PMA/PMN Number: K851962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ZSO-7-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2011
• Event Location: Hospital
• Date Manufacturer Received: 05/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR