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

Catalog Number RMS-060022-R

Device Problems Calcified (1077); Complete Blockage (1094); Infusion or Flow Problem (2964)

Patient Problem Failure of Implant (1924)

Event Date 01/03/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

As initially reported to customer relations via phone discussion with the district manager: a patient of unknown age and gender had a resonance stent implanted in a previous procedure.The physician was to remove the stent however the stent was calcified in the bladder and possibly in the kidney.The physician is to perform an eswl procedure in attempt to break up the calcification.The physician at the time of notification did not have the procedure scheduled.Additional information per the physician & district manager: unable to remove stent, appeared encrusted distally in bladder, would no uncurl proximally.This is not her first metallic stent, prior one did fine for over a year.An eswl procedure is scheduled for the week of (b)(6) 2020.

Manufacturer Narrative

1 x rms-060022-r of unknown lot number was not returned to cirl for a lab evaluation.Therefore a document based investigation was completed.Prior to distribution rms-060022-r 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.A review of the manufacturing records for rms-060022-r of unknown lot number could not be completed.The instructions for use, which accompanies this device warns of 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¿.It may be noted that according to the instructions for use, instructs the user in step 7: ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ there is not sufficient evidence to suggest that the user did not follow the instructions for use.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to encrustation on the stent.The planned removal of the could not be completed as it "appeared encrusted distally in bladder, would no uncurl proximally." the physician preformed an eswl procedure in attempt to break up the calcification.During the second attempt to remove the stent, lithotripsy (eswl) was performed on the proximal end of the stent and this resulted in the successful removal.It is clear the encrustation present on the stent impeded its removal.The root cause of the calcification/encrustation may be the result of the patient's anatomical environment and pre-existing conditions.It is known she previously had metallic stents placed and it is planned to continue with an additional metallic stent in the future.The patient is had a previous ovarian tumour and previous pelvis surgery which has resulted in chronic hydronephrosis.Complaint is confirmed based on the customer¿s testimony.The first planned removal of the stent was unsuccessful, a second procedure occurred, which was lithotripsy (eswl) on the proximal end of the stent and removed it, another stent was placed and they placed to exchange that in a number of weeks with an new metallic stent.The patient's condition was reported as fine post operation.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

As initially reported to customer relations via phone discussion with the district manager: a patient of unknown age and gender had a resonance stent implanted in a previous procedure.The physician was to remove the stent however the stent was calcified in the bladder and possibly in the kidney.The physician is to perform an eswl procedure in attempt to break up the calcification.The physician at the time of notification did not have the procedure scheduled.Additional information per the physician & district manager: unable to remove stent, appeared encrusted distally in bladder, would no uncurl proximally.This is not her first metallic stent, prior one did fine for over a year.An eswl procedure is scheduled for the week on (b)(6) 2020.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 9647562
• MDR Text Key: 177168154
• Report Number: 3001845648-2020-00068
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/28/2020

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: RMS-060022-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/03/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 01/30/2020
• Supplement Dates Manufacturer Received: 01/03/2020
• Supplement Dates FDA Received: 04/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 104