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

Catalog Number UNKNOWN

Device Problems Off-Label Use (1494); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Gastrointestinal Hemorrhage (4476)

Event Date 10/03/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Jagielski et al 2022 endoscopic treatment of pancreaticopleural fistulas.Endoscopic procedures were performed under general anesthesia with tracheal intubation.All patients provided informed consent for the endoscopic procedures.All procedures were performed by a single endoscopist, and entailed carbon dioxide insufflation and the use of a linear echoendoscope (pentax eg3870utk, pentax medical, (b)(6), japan), duodenoscope (olympus tjf-q180v, olympus corporation, (b)(6), japan), and gastroscope (olympus gifh185, olympus corporation) [16].Transpapillary drainage: attempts to perform ercp to assess the morphology and integrity of the mpd and to employ possible endoscopic treatment were made in all patients with post-inflammatory ppf treated in our center (figures 1a¿f).In the case of disruption of the mpd, sphincterotomy (fusion omni sphincterotome fs-omni-35-480, cook endoscopy inc., north carolina, usa) was performed and a pancreatic 5 fr, 7 fr, 8.5 fr, or 10 fr endoprosthesis (zimmon pancreatic stent, cook, endoscopy inc., north carolina, usa) was introduced into the mpd and subsequently replaced every 1, 3, 6, 12, or 24 months or until no contrast leakage outside the duct was identified.Transmural drainage: if transpapillary access was not possible, transmural access (through the wall of the upper gastrointestinal tract) was obtained using the single transluminal gateway technique (sgt) (figures 2a¿d).Placement of the pancreaticogastric anastomosis in the form of a transmural cystostomy was performed under eus guidance.Anastomosis between the lumen of the gastrointestinal tract and the fistula canal was created using a 10 fr cystotome (cystotome cst-10, cook endoscopy inc., north carolina, usa) and then dilated using a high-pressure balloon with a diameter of up to 15 mm (cook endoscopy inc., north carolina, usa).A transmural 7 fr or 8 fr double-pigtail stent (cook endoscopy inc., north carolina, usa) was inserted through pancreaticogastrostomy.For active transmural drainage, a 7 fr or 8.5 fr nasal drain (cook endoscopy inc., north carolina, usa) was inserted into the canal of the fistula through pancreaticogastric anastomosis.In cases of passive transmural drainage, only 7 fr or 8 fr double-pigtail stents (cook endoscopy inc., north carolina, usa) were used through the transmural anastomosis.This file will capture 3 cases of procedural bleeding requiring transfusion.(21 men and 1 woman; mean age 49.52 [30¿67] years) with pancreatitis.In 19/22 (86.36%) patients, ppf communicated with the left pleural cavity and in 3/22 (13.64%) patients with the right pleural cavity.

Manufacturer Narrative

Device evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.This file was created from the attached journal article "endoscopic treatment of pancreaticopleural fistulas" complaint files (b)(4) were opened as a result of this paper.(b)(4) was opened to capture 12 of off-label use with the zimmon biliary stent.(b)(4) was opened to capture 03 cases of off-label use and procedural bleeding.(b)(4) was opened to capture 01 case of off-label use and sepsis.(b)(4) was opened to capture 22 cases of user error of the zimmon pancreatic stent exceeding the recommended indwell period.Manufacturing records: manufacturing records review could not be completed as the lot number is unknown.Review historical data: historical data was not reviewed as the lot number is unknown.Instructions for use and label: as per the precautions in the instructions for use (ifu0055) , "this device is used to drain obstructed pancreatic ducts" and in the notes section ¿do not use this device for any purpose other than stated intended use.¿ it is also stated in the potential complications section: ¿those associated with ercp include but are not limited to: pancreatitis, cholangitis, aspiration, perforation, hemorrhage, infection, sepsis, allergic reaction to contrast or medication, hypotension, respiratory depression or arrest, cardiac arrhythmia or arrest¿.There is evidence to suggest that the customer did not follow the instructions for use.(ifu0055) image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause can be attributed to the off-label use of the device, when the device is outside it stated intended use.In this case the stent was used for transmural drainage for the treatment of pancreaticopleural fistulas, which is a contradiction of the intended use of the device.As per the ifu, this device is used to drain obstructed pancreatic ducts.Medical advisor input confirmed that the bleeding was related to the transmural/transgastric drainage which was off-label use.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer, off-label use & bleeding confirmed quantity of 03 devices, confirmed used.According to the information reported, the 03 patients who experienced bleeding required a transfusion.Investigation findings conclude a definitive root cause can be attributed to the off-label use of the device, when the device is outside it stated intended use.In this case the stent was used for transmural drainage for the treatment of pancreaticopleural fistulas, which is a contradiction of the intended use of the device.As per the ifu, this device is used to drain obstructed pancreatic ducts.Medical advisor input confirmed that the bleeding was related to the transmural/transgastric drainage which was off-label use.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 08-apr-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: 17641100
• MDR Text Key: 322157669
• Report Number: 3001845648-2023-00651
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K900923
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/03/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/31/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 07/31/2023
• Supplement Dates FDA Received: 05/02/2024
• 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: 50 YR
• Patient Sex: Male