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

Model Number G34110

Device Problem Migration (4003)

Patient Problems Fistula (1862); No Consequences Or Impact To Patient (2199)

Event Date 11/29/2020

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.) (b)(4).This report is for the report of a stent migration.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? - yes.The migrated resonance stent.If yes, from what part of the body and what instrument was used to remove it? unknown.Current storage conditions - staged in operation room.Why was the stent removed? (exchange? or other issues?) migrated stent needed to be exchanged.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.

Manufacturer Narrative

Device evaluation 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.(b)(4).(report reference number - 3001845648-2020-00973) covers the symptoms and events occurred after the migrated resonance stent was removed and the other manufacturers polymer stent was placed.Lab evaluation n/a.Document review 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 a 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 (b)(4) in the warning section instructs: arterioureteral 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 (ifu020-18) states the following: ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).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 be attributed to a known inherit risk of the device.The potential adverse effects are included in the information of use.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, it is unknown it the patient suffered any adverse affects as a result of the stent migration.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.

Manufacturer Narrative

Device evaluation: 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.(b)(4) (report reference number - 3001845648-2020-00973) covers the symptoms and events occurred after the migrated resonance stent was removed and the other manufacturers polymer stent was placed.Document review: 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 a 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 (uro-p034-s17-r03) 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 (ifu020) 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.Root cause review: a definitive root cause could be attributed to a known inherit risk of the device.The potential adverse effects are included in the information of use.As per medical advisor "there is not enough info here to determine the exact cause of the stent migration (ie.Was the stent sized and placed correctly, did radiotherapy shrink the external obstruction etc) but this would not be an usual adverse event even when stent has been placed/sized correctly.Stent migration is listed as a pae in the ifu." summary: the complaint is confirmed based on customer testimony.According to the initial reporter, it is unknown it the patient suffered any adverse affects as a result of the stent migration.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to update the investigation.

• 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: 11047064
• MDR Text Key: 229183450
• Report Number: 3001845648-2020-00974
• 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,Followup
• Report Date: 06/07/2022

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?: Yes
• 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: 11/29/2020
• 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