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

Model Number	G34110
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Serious Injury
Additional 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.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations, "attempted removal of the device.There was a tumor that had invaded the stent.While attempting to pull out the stent, the stent fractured and a piece was left indwelling.Due to the patients age, an intervention was not performed and the patient is being monitored." per complaint form: stent was placed in patient (b)(6) 2018 & attempted to be removed (b)(6) 2019, the stent started to unravel and it was left in place.They then did a second attempt and that is when the stent broke.A piece of the stent is still in the patient and a bard optima inlay (6=26) stent was inserted without any problems.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 based on the requirement for surgical intervention to remove the broken stent piece and also based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling".
Event or Problem Description
As reported to customer relations, "attempted removal of the device.There was a tumor that had invaded the stent.While attempting to pull out the stent, the stent fractured and a piece was left indwelling.Due to the patients age, an intervention was not performed and the patient is being monitored." per complaint form: stent was placed in patient (b)(6) 2018 & attempted to be removed (b)(6) 2019, the stent started to unravel and it was left in place.They then did a second attempt and that is when the stent broke.A piece of the stent is still in the patient and a bard optima inlay (6=26) stent was inserted without any problems.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 based on the requirement for surgical intervention to remove the broken stent piece and also based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling".
Additional Manufacturer Narrative
Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (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.
Additional 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: (b)(4).Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Event or Problem Description
As reported to customer relations, "attempted removal of the device.There was a tumor that had invaded the stent.While attempting to pull out the stent, the stent fractured and a piece was left indwelling.Due to the patients age, an intervention was not performed and the patient is being monitored.".Per complaint form: stent was placed in patient (b)(6) 2018 & attempted to be removed (b)(6) 2019, the stent started to unravel and it was left in place.They then did a second attempt and that is when the stent broke.A piece of the stent is still in the patient and a bard optima inlay (6=26) stent was inserted without any problems.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 based on the requirement for surgical intervention to remove the broken stent piece and also based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling".
Additional Manufacturer Narrative
Device evaluation the rms-060024-r device of lot number c1392538 involved in this complaint was not available for evaluation.With the information provided, a document based investigation was conducted.Document review prior to distribution rms-060024-r devices are subjected to a visual inspection and functional checks to ensure device integrity.A review of the manufacturing records for rms-060024-r of lot number c1392538 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 c1392538.It should be noted that the instructions for use (ifu0020-16) states the following: ¿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.¿ root cause review: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to the user leaving the stent in place for longer than the recommended indwell time and/or difficult patient anatomy.From the information provided it is known that the stent was left indwelling for 13 months.The ifu instructs that the stent should not remain in place for more than 12 months.It is also known that a tumour had invaded the stent during this time.It is possible that this also contributed to the stent fracturing on attempted removal.Summary the complaint is confirmed based on customer testimony.According to the initial reporter, an additional stent was placed as a result of this occurrence.The fractured piece of stent was surrounded by soft tissue and was left indwelling by the physician.From the information provided it is known that the patient remains asymptomatic.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
As reported to customer relations, "attempted removal of the device.There was a tumor that had invaded the stent.While attempting to pull out the stent, the stent fractured and a piece was left indwelling.Due to the patients age, an intervention was not performed and the patient is being monitored." per complaint form: stent was placed in patient on (b)(6) 2018 & attempted to be removed on (b)(6) 2019, the stent started to unravel and it was left in place.They then did a second attempt and that is when the stent broke.A piece of the stent is still in the patient and a bard optima inlay (6=26) stent was inserted without any problems.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 based on the requirement for surgical intervention to remove the broken stent piece and also based on the device malfunction reporting precedence for this device family for the issue of ¿stent fracture/breakage/uncoiling".

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 8648782
• Report Number: 3001845648-2019-00230
• Device Sequence Number: 2087401
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)200824(10)C1392538
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 07/24/2019

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: 08/24/2020
• Device Model Number: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1392538
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/29/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 05/08/2019
• Supplement Date Received by Manufacturer: 05/08/2019; 05/08/2019; 05/08/2019
• Initial Report FDA Received Date: 05/29/2019
• Supplement Report FDA Received Date: 06/26/2019; 07/24/2019; 08/21/2019
• 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