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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pancreatitis (4481)

Event Date 05/05/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As reported to customer relations via pmcf / literature complaint form "as reported to customer relations via pmcf / literature complaint form "final report pancreatic stent pmcf (b)(4) - indication for ercp (endoscopic retrograde cholangiopancreatography) procedure used for placing the study device and the duct study device was placed in are reported in table 3.2-1.Most common indication for the procedure was chronic pancreatitis (53.1%), followed by prophylaxis for post-ercp pancreatitis (pep) (35.9%), and pancreatic stone (33.6%).Most patients (89.1%) had the stent placed in pancreatic duct with close to 10% patients receiving the stent in the biliary ductal system." final report pancreatic stent pmcf (b)(4)- indication for ercp (endoscopic retrograde cholangiopancreatography) procedure used for placing the study device and the duct study device was placed in are reported in table 3.2-1.Most common indication for the procedure was chronic pancreatitis (53.1%), followed by prophylaxis for post-ercp pancreatitis (pep) (35.9%), and pancreatic stone (33.6%).Most patients (89.1%) had the stent placed in pancreatic duct with close to 10% patients receiving the stent in the biliary ductal system.This complaint captures 5 cases of pancreatitis.Related file (b)(4) captures stent migration.

Manufacturer Narrative

Device evaluation: the 05 x zimmon pancreatic stents of unknown lot number and rpn were involved in this complaint.With the information provided, a document-based investigation was conducted.This complaint captures 5 cases of pancreatitis.This file was created in response to pmcf / literature complaint form "final report pancreatic stent pmcf mdr-2062¿.Pr¿s also open in relation to this pmcf study are as follows: pr(b)(4) -pancreatic stent pmcf-off label use.Pr(b)(4) -pancreatic stent pmcf-pain/discomfort and fever.Pr(b)(4) -pancreatic stent pmcf ¿ post-ercp unintended stent migration.Pr(b)(4) -pancreatic stent pmcf-hemhorrage.The device lab evaluation could not be completed as the device, or photographic evidence of the device, was not returned for evaluation.Manufacturing records review: prior to distribution all pancreatic plastic stent devices are subjected to a visual inspection and functional inspection to ensure device integrity.Manufacturing records review could not be completed as the lot number is unknown.Historical data review: historical data was not reviewed as the lot number is unknown.Manufacturing records review: as per the ifu (0055) intended use statement ¿this device is used to drain obstructed pancreatic ducts¿.As per instructions for use, ifu0055 which accompanies this device, potential complications section: "potential complications associated with ercp include, but are not limited to: pancreatitis, cholangitis, perforation, haemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest.Those associated with biliary stent placement include but are not limited to: trauma to the biliary tract or duodenum, obstruction of the pancreatic duct, stent migration".Pancreatitis is a known potential adverse events associated with an endoscopic procedure (i.E., ercp procedure) during which a plastic biliary or pancreatic stent is being placed.There is no evidence to suggest the customer did not follow the instructions for use.Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patients pre-existing/underlying conditions.As per instructions for use, pancreatitis is listed as a complication following the use of this device.According to the pmcf study the most common significant adverse event after ercp is post -ercp pancreatitis (pep).Confirmation of complaint: the complaint is confirmed based on customer/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: failure identified: as per customer/ or rep testimony the 05 x zimmon pancreatic stent case of post-ercp pancreatitis of unknown pancreatic stents pmcf.Confirmed quantity of 05 devices, used.Investigation findings conclude a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the patients pre-existing/underlying conditions.As per instructions for use, pancreatitis is listed as a complication following the use of this device.The complaint is confirmed based on customer/or rep testimony.As per medical advisor¿s input ¿require intervention/additional procedures s=3 or s=4 depeding on how severe the pancreatitis was" complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplement report being submitted due to the completion of the investigation on 13-mar-2024.

• Brand Name: ZIMMON PANCREATIC 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: 17859720
• MDR Text Key: 324776172
• Report Number: 3001845648-2023-00751
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• 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: 05/05/2023
• Event Location: Hospital
• Date Manufacturer Received: 09/11/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female