MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER; FAD STENT, URETERAL

Catalog Number UNKNOWN

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problems Micturition Urgency (1871); Urinary Tract Infection (2120); Urinary Frequency (2275); Dysuria (2684)

Event Date 06/07/2020

Event Type  Injury  

Manufacturer Narrative

Information pertaining to user facilty as follows: department of urology, (b)(6).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Case 2.Patient experienced stent migration and repeated metallic stent infections stent had migrated, the patient developed a urinary tract infection, with frequent urination, urinary urgency and dysuria; she was admitted again on (b)(6) 2016.The stent was subsequently replaced with a shorter one (26 cm to 24cm) because of her long legs and compact trunk.Her symptoms resolved after the operation.

Manufacturer Narrative

Device evaluation: the unknown rms devices of unknown lot numbers involved in this complaint were not available for evaluation.With the information provided, a document based investigation was conducted.This file was created from the journal article."gao - metallic ureteral stent in restoring kidney function ".The paper describes the characteristics of patient who received metallic ureteral stents to restore kidney function due to idiopathic retroperitoneal fibrosis.It examines 9 patient's treatments with metallic ureteral stents (rms).Within the attached paper in "table 1 -characteristics of patient who received metallic ureteral stents to restore kidney function due to idiopathic retroperitoneal fibrosis", described the adverse effects experienced by the 9 patients discussed in the paper.Complaint files (b)(4) (mdr ref #3001845648-2020-00597), (b)(4) (mdr ref #3001845648-2020-00594), (b)(4) (mdr ref #3001845648-2020-00595) & (b)(4) (mdr ref #3001845648-2020-00596) were opened as a result of this paper.This compliant file (b)(4) (mdr ref #3001845648-2020-00597) relates to case 2 in the study, where the patient experienced stent migration and repeated metallic stent infections.The stent had migrated, the patient developed a urinary tract infection, with frequent urination, urinary urgency and dysuria; compliant file (b)(4) (mdr ref #3001845648-2020-00594) relates to case 4 in the study, where the patient experienced postoperative hematuria because he resumed normal activities after stent placement, contrary to instructions the patient.He remained physically active, which presumably led to repeated hematuria.A laparotomy was then performed for stent removal in the other institution.In (b)(6) 2016, this patient was reported to have kidney dysfunction and leg edema.We recommended metallic stent placement, but he refused.Compliant file (b)(4) (mdr ref #3001845648-2020-00595) relates to case 5, case 7 and case 9 in the study, where the stents were indwelling longer the 12 month.Case 5: this patient received a right metallic stent in (b)(6) 2013.On (b)(6) 2014, the stent was replaced with a polymeric stent.Case 7: in (b)(6) 2015, a bilateral metallic stents were placed for this patient, and ureteral obstruction was relieved.The stents were refreshed in (b)(6) 2016.Case 9: after this patient received a 26 cm metallic stent in (b)(6) 2013, the patient was again admitted into the department of urology on (b)(6) 2014, and the metallic stent was refreshed.On (b)(6) 2016 the metallic stent was refreshed.On (b)(6) 2017 contrast revealed that drainage of the left ureteral lumen was ensured by the metallic stent without obstruction ¿(indwelling longer that 12 months)   compliant file (b)(4) (mdr ref #3001845648-2020-00596) relates to case 9 in the study, where the stent placed in (b)(6) 2013 was found to have migrated on (b)(6) 2014.As the rpn and lot number of the complaint devices are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution rms-060026-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 the unknown rms device could not be completed as the lot number was unknown.It should be noted that the instructions for use (ifu0020-17) states the following: intended use " used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.Intended for one-time use".¿warnings: these stents are not intended as permanent indwelling devices.The stent must not remain indwelling more than twelve (12) months.If the patient¿s status permits, the stent may be replaced with a new stent.Patients should be checked at regular interval utilizing techniques such as abdominal x-ray (kub film).Patient 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, ifu0020-17, the user is instructed that ¿hematuria and incontinence may indicate fistula formation.¿ per the instructions for use (ifu0020-17) states the following potential events: loss of renal function, pain/discomfort, hydronephrosis, stent dislodgement / migration.Urinary symptoms (frequency, urgency, incontinence, dysuria, hematuria)" there is evidence to suggest that the customer did not follow the instructions for use (ifu0020-17).5.Root cause review a definitive root cause could be attributed to the stent in place for longer than the recommended indwell time.From the information provided it is known that the stent placed in (b)(6) 2014 was then replaced by a third stent to the right in 2016.This was the stent which was reported to have migrated and this stent was left indwelling for greater 12 months.The ifu instructs that the stent should not remain in place for more than 12 months.This increase in indwell time could have resulted in prolonged forces on the stent and possible contributed to resulting in the movement.Also when the stent was replaced it was replaced with a shorter stent due to the patient's anatomy, so the initial stent may have been too long for the patient.This longer length may have led stent to receive increased forces on the stent due to lack on clearance within implant location.Complaint is confirmed based on customer testimony.Case 2: patient experienced stent migration and repeated metallic stent infections.The stent had migrated, the patient developed a urinary tract infection, with frequent urination, urinary urgency and dysuria.This stent was replaced on (b)(6) 2016, with a shorter stent (26cm to 24cm) because of long legs and compact truck.Her symptoms resolved after the operation.She received follow-up visits every 3 months, including ultrasonography and currently remains symptom-free.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The investigation was concluded on the (b)(6) 2021, this supplement report is being submitted to include the investigation conclusions.

• Brand Name: RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10510360
• MDR Text Key: 206361506
• Report Number: 3001845648-2020-00597
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/13/2021

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
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/07/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/11/2020
• Initial Date FDA Received: 09/09/2020
• Supplement Dates Manufacturer Received: 08/11/2020
• Supplement Dates FDA Received: 09/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR