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

Catalog Number RMS-060024-R

Device Problem No Flow (2991)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations, "two (bilateral) rms stents were placed in a patient in may but had to be withdrawn from the patient yesterday.Resonance stents that stopped draining." 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 the stents had to be removed from the patient also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

As reported to customer relations, "two (bilateral) rms stents were placed in a patient in may but had to be withdrawn from the patient yesterday.Resonance stents that stopped draining." fda mdr reporting required: this event meets the criteria of an fda ¿serious injury¿ report as per fda guidelines ¿medical device reporting for manufacturer's (2016)¿ section 2.13 and 2.15 as the stents had to be removed from the patient also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

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

Event Description

As reported to customer relations, "two (bilateral) rms stents were placed in a patient in may but had to be withdrawn from the patient yesterday.Resonance stents that stopped draining." 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 the stents had to be removed from the patient also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Cook medical incorporated (cmi) 1025 acuff road p.O box 4195 bloomington indiana 47402-4195.Importer site establishment registration number: 3005580113.Device evaluation: 2 x rms-060024-r devices of lot number c1562394 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 06th of september 2019.During the evaluation both devices appear unused and with no visual defects.Image review ¿ n/a.Document review: prior to distribution rms-060024-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-060026-r of lot number c1562394 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 c1562394.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).Use of this device should be based upon consideration of risk-benefit factors as they apply to your patient.Informed consent should be obtained to maximize patient compliance with follow-up procedures¿.Also, with the instructions for use, within the potential adverse events it warns of ¿diminished urine drainage/ stent occlusion¿ a final warning in the instructions for use indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿.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 it may be as the result of compression by a tight stricture, as per instructions for use, diminished urine drainage/ stent occlusion is listed as a complication following the placement of the device.It has been requested from the customer when was it detected that rms stent ceased functioning as intended.It also been requested to know what the patient¿s pre-existing condition was and requested were details on the patient outcome and the additional procedures that occurred as a result of this issue.Should this information be received, the file will be updated accordingly.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 did require additional procedures as result of this occurrence and there have been adverse effects on the patient.However, the details of the effects on the patient have not been provided.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations, "two (bilateral) rms stents were placed in a patient in may but had to be withdrawn from the patient yesterday.Resonance stents that stopped draining." 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 the stents had to be removed from the patient also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.No adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining to section g.1 as follows: importer site contact and address: (b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations, "two (bilateral) rms stents were placed in a patient in may but had to be withdrawn from the patient yesterday.Resonance stents that stopped draining." 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 the stents had to be removed from the patient also reportable based on the device malfunction reporting precedence for this device family for the issue of ¿stent does not drain'.No adverse effects to the patient have been reported as occurring.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; national technology park; limerick
• MDR Report Key: 8761978
• MDR Text Key: 150125912
• Report Number: 3001845648-2019-00303
• 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,Followup,Followup,Followup
• Report Date: 09/26/2019

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
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1562394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/04/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/04/2019
• Supplement Dates Manufacturer Received: 07/12/2019; 07/12/2019; 06/12/2019; 06/12/2019
• Supplement Dates FDA Received: 08/01/2019; 08/29/2019; 09/26/2019; 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 72