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

Model Number	G34111
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Renal Failure (2041)
Date of Event	08/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Both the stents got blocked and patient developed acute renal failure.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as both the stents got blocked and patient developed acute renal failure and based on the assumption that intervention would be required to remove the devices, also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.
Additional Manufacturer Narrative
Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
Both the stents got blocked and patient developed acute renal failure.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as both the stents got blocked and patient developed acute renal failure and based on the assumption that intervention would be required to remove the devices, also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.
Additional Manufacturer Narrative
Device evaluation: 1 x rms-060026-r devices of lot number (b)(6) involved in this complaint was returned for evaluation, without the original packaging.With the information provided, a physical examination and document-based investigation was conducted.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation on the 27th of september 2019.On evaluation of the stent had evidence of encrustation on the body and pigtail of the stent.The rms stent was cut, and encrustation debris did fall out of the cut stent, the stent was not blocked internally.Image review ¿ n/a.Document review: prior to distribution rms-060026-r devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for rms-060026-r of lot number (b)(6) did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number (b)(6).The instructions for use, ifu, which accompanies this device instructs the end user to ¿ patients should be checked at regular intervals 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 should also be noted that the ifu lists diminished urine drainage / stent occlusion/ stent encrustation/ pain/discomfort as a known potential adverse event.There is no evidence to suggest that the customer did not follow the instructions for use.Root cause review: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to patient condition related.The stent had evidence of encrustation present, this encrustation on the coils of the metallic stent would indicate a possible interaction with the stricture site.The patient¿s existing condition of bilateral ureteric stricture post radiotherapy could have created an environment within the patient where encrustation could have developed on the stent.The fact a previously placed stent became blocked during indwell period, would indicate the patient¿s anatomical environment maybe a contributory factor.The stricture site may have had some damaged or inflamed tissue, which due to the design of the resonance stent with an open coiled metallic stent, this tissue like material could have advanced into the lumen of stent, causing the stent to become blocked and ceased draining, this blockage of the stent could have contributed to the severe pain experienced by the patient after the insertion of the stent.A polymer stent was placed at same location once the rms stent was removed, according to the reporter, and the patient condition became stable.The polymer stent has a closed outside circumference, which would prevent tissue like material penetrating the inner lumen of the stent and this could be why this type of stent performed better within this patient than the metallic open coiled stent.As per instructions for use, diminished urine drainage/ stent occlusion/ stent encrustation and pain/discomfort are listed as a complication following the placement of the device.Summary: complaint is confirmed based on the customers testimony as the clinical setting that could impact on the functionality of the device cannot be replicated in the laboratory.According to the initial reporter, the patient developed acute renal failure when stent ceased draining, a secondary procedure was required, and different stent was placed.The patient¿s condition has improved, and they are not experiencing pain or irritation.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Both the stents got blocked and patient developed acute renal failure.Fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿ section 2.13 and 2.15 as both the stents got blocked and patient developed acute renal failure and based on the assumption that intervention would be requied to remove the devices, also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8968503
• Report Number: 3001845648-2019-00454
• Device Sequence Number: 14099560
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)200919(10)C1401420
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K063742
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/19/2020
• Device Model Number: G34111
• Device Catalogue Number: RMS-060026-R
• Device Lot Number: C1401420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/24/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/13/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 08/14/2019; 08/14/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/03/2019; 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention