MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED; ESW PROSTHESIS, ESOPHAGEAL

Model Number G48031

Device Problems Detachment Of Device Component (1104); Material Separation (1562); Delivery System Failure (2905)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 02/23/2018

Event Type  Injury  

Manufacturer Narrative

Pma/510k= k162717.(b)(4).Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

Malfunctioned evolution stent.Additional information received 2nd mar 2018 dw the tip of the introducer (the tulip) came off in the patient while deploying the stent.They finished the case with a second stent.

Manufacturer Narrative

Pma/510k= k162717.(b)(4).Exemption number: e2016031.(b)(4).Problem statement: malfunctioned evolution stent.Additional information received 2nd mar 2018.The tip of the introducer (the tulip) came off in the patient while deploying the stent.They finished the case with a second stent.Device evaluation: the evo-20-25-10-e device of lot number c1338525 was returned to cook (b)(4) and evaluated on the 11-april-2018.Lab evaluation: upon evaluation of the returned device, no lockwire was returned with the device.The red shuttle deployment marker was at the back of the handle.It was noted that it was the peak tubing that broke, not the joint of the tip.The peak tubing should measure 210.5 +/-5cm, however it only measured 189cm.It was noted that the peak tubing broke 4mm into the tip.Customer complaint confirmed as failure was verified in laboratory.The tip was detached from the introducer when the device was returned.Following the lab evaluation, the following queries were sent to the originator: did any part of the device remain inside the patient? where is the stent? at which point did the tip fall off? did the user retract or reposition at any point? was there excessive force used? was the patient anatomy torturous? there queries are still pending and the investigation will be updated once a response is received.Root cause: additional information is currently pending from the patient, so a definite root cause cannot be determined.Once this information is received, the root cause will be updated.Document review: a review of the incoming quality control records for components did not reveal any discrepancies which could have contributed to this complaint issue.Prior to distribution all evo-20-25-10-e 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 cook (b)(4).A review of the manufacturing records for evo-20-25-10-e device of lot number c1338525 did not reveal any discrepancies that could have contributed to this issue.Summary: customer complaint confirmed as failure was verified in laboratory.The tip was detached from the introducer when the device was returned.According to the information provided, a section of the device did not remain inside the patient, the procedure was finished using a second device.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Malfunctioned evolution stent.Additional information received 2nd mar 2018 dw the tip of the introducer (the tulip) came off in the patient while deploying the stent.They finished the case with a second stent.

Event Description

Correction report is being submitted to update reporting reasons to serious injury as a 2nd stent was required after the malfunction.Malfunctioned evolution stent.Additional information received 2nd mar 2018 dw the tip of the introducer (the tulip) came off in the patient while deploying the stent.They finished the case with a second stent.

Manufacturer Narrative

Pma/510k= k162717.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), 1025 acuff road, p.O box 4195, bloomington, indiana 47402-4195.Importer site establishment registration number: (b)(4).This correction report is being submitted to update the reason for reporting to serious injury as it was confirmed that a 2nd stent had to be placed after the malfunction led to the 1st stent deploying in the wrong position.

Manufacturer Narrative

Pma/510k= k162717.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 risk and root cause.

Event Description

Malfunctioned evolution stent.Additional information received 2nd mar 2018.The tip of the introducer (the tulip) came off in the patient while deploying the stent.They finished the case with a second stent.

Manufacturer Narrative

Pma/510k= k162717.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Information pertaining (b)(6).Importer site establishment registration number: (b)(4).Device evaluation: the evo-20-25-10-e device of lot number c1338525 was returned to cook ireland and evaluated.Lab evaluation: upon evaluation of the returned device, no lockwire was returned with the device.The red shuttle deployment marker was at the back of the handle.It was noted that it was the peek tubing that broke, not the joint of the tip.The peek tubing should measure 210.5 +/-5cm, however it only measured 189cm.It was noted that the peek tubing broke 4mm into the tip.The tip was detached from the introducer when the device was returned.Customer complaint confirmed as failure was verified in laboratory.Following the lab evaluation, queries were sent to the originator, the following was received: 1) did any part of the device remain inside the patient? yes, the tulip.They did not retrieve the tulip to not displace the stent further and they felt the tulip would easily pass.2) where is the stent? in the oesophagus.3) at which point did the tip fall off? during deployment 4) did the user retract or reposition at any point? no 5) was there excessive force used?no 6) was the patient anatomy torturous?no root cause: as no imaging has been provided a definite root cause of this complaint cannot be determined.However although additional information reported there was no excessive force, cirl engineering commented that some force would need to have been applied during deployment which resulted in the tip coming off in the patient, as it was the peak tubing that broke, not the joint of the tip.Document review: the evo-20-25-10-e device of lot number c1338525 contains irs0043 (evo-20-25-10-e second assembly) of lot ch1331016 and rmn28-096 (ntts introducer tip, pebax 3533 with 40%).They are the components involved in this complaint.Rmn28-096 (ntts introducer tip, pebax 3533 with 40%) is supplied by the vendor creganna.Once received at cook ireland, the tip is subject to incoming inspection.A review of the incoming quality control records for component rmn28-096 did not reveal any discrepancies which could have contributed to this complaint issue.Prior to distribution all evo-20-25-10-e 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 evo-20-25-10-e device of lot number c1338525 did not reveal any discrepancies that could have contributed to this issue.Summary: customer complaint confirmed as failure was verified in laboratory.The tip was detached from the introducer when the device was returned.According to the information provided, a section of the device did not remain inside the patient, the procedure was finished using a second device.

Event Description

Reporting based on precedence "tip separation".Malfunctioned evolution stent.Additional information received 2nd mar 2018 the tip of the introducer (the tulip) came off in the patient while deploying the stent.They finished the case with a second stent.

• Brand Name: EVOLUTION® ESOPHAGEAL CONTROLLED-RELEASE STENT - PARTIALLY COVERED
• Type of Device: ESW PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 7361552
• MDR Text Key: 103678996
• Report Number: 3001845648-2018-00142
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 10827002480312
• UDI-Public: (01)10827002480312(17)190321(10)C1338525
• Combination Product (y/n): N
• 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: 05/17/2018

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 Model Number: G48031
• Device Catalogue Number: EVO-20-25-10-E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/22/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/22/2018
• Supplement Dates Manufacturer Received: 02/23/2018; 02/23/2018; 02/23/2018; 02/23/2018
• Supplement Dates FDA Received: 04/19/2018; 05/17/2018; 06/15/2018; 10/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention