MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD STENT, URETERAL

Model Number G34110

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

Patient Problems Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 12/01/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

On (b)(6) 2020: stent exchange was performed.The physician removed a resonance stent that had been placed for 12 months and placed the new resonance stent.On (b)(6) 2020: the physician found the resonance stent has migrated, so he removed it and placed bard's inlay optima stent.((b)(4)).On (b)(6) 2020: blood in the patient's urine was confirmed.On (b)(6) 2020: decrease in blood pressure, major bleeding from the urinary tract and hemorrhagic shock were confirmed.The physician found hematoma in the kidney in the ct image, so he determined ureteroarterial fistula has been developed in the external iliac artery but could not locate the exact bleeding site.So he removed only the hematoma in the bladder.The bleeding stopped but hematoma remains in the urinary tract.The physician is taking a wait-and-see approach.The physician commented as 'the event occurred after the resonance stent was exchanged with other manufacturer's polymer stent, so i can't determine if indwelling resonance stent was the cause of fistula.However i can't deny any relationship with resonance stent(s) that was/were placed for a long time.There is no information about patient's outcome as of today.The physician is taking a wait-and-see approach.Did anything have to be removed from the patient? - no.If yes, from what part of the body and what instrument was used to remove it? - n/a.Current storage conditions - straged in operation room.Why was the stent removed? (exchange? or other issues?) - exchange.What was the length of the indwell time? - less than 4 months.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? - after.What wire guide did they use? - unknown.Did they attempt to attach the tapered end of the stent to the inserter? n/a.Was this device assembled outside of the body? - yes.Did the device come with a pigtail straightener? - yes.If yes, was the pigtail straightener used? - yes.Questions for metallic resonance (rms) stents: was the stent stored in strong light (e.G.In a in a pyxis machine) or in direct sunlight? - no was there difficulty advancing the stent to the target location? - no.How long was the stent in-dwelling? - less than 4 months.What was used to remove the stent? - rigid cystoscope.How often was the stent checked during the in-dwelling time? - unknown.What method was used? - unknown.Was the patient using calcium supplementation? - unknown.Was force required to remove the stent? - no.Was encrustation evident on the stent? - no.What is the source of the extrinsic compression? - unknown.If caused by a tumor, what is the tumor type? what is the stage of the tumor? - unknown.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

The resonance stent set device of unknown lot number involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.As the rpn and lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution all resonance stent set devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The japanese packaging insert which accompanies this device in the warning section instructs: "aterioureteral fistula formation between ureter and aorta or iliac artery may occur to patients with past history of pelvic operation or/and radiotherapy and long-term indwelling of ureteral stent." it should be noted that the instructions for use states the following: ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub flim).Patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿.There is no is evidence to suggest the user did not follow the ifu.A definitive root cause could not be determine with the available information.A possible root cause could be attributed to the patients history.The tissue of the ureter would have been ¿weakened¿ perhaps by radiotherapy etc and the resonance stent, by being in the ureter, could have contributed to erosion of this tissue into the artery.The formation of a uretero-arterial fistula would be recognised complication of the use of ureteral stents.The complaint is confirmed based on customer testimony.According to the initial reporter, blood in the patient's urine was confirmed.Decrease in blood pressure, major bleeding from the urinary tract and hemorrhagic shock were confirmed.The physician found hematoma in the kidney in the ct image, so he determined ureteroarterial fistula has been developed in the external iliac artery but could not locate the exact bleeding site.So he removed only the hematoma in the bladder.The bleeding stopped but hematoma remains in the urinary tract.The physician is taking a wait-and-see approach complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 11047097
• MDR Text Key: 231174487
• Report Number: 3001845648-2020-00973
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)230423(10)C1728351
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1728351
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/01/2020
• Event Location: Hospital
• Date Manufacturer Received: 12/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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 Sex: Male