MAUDE Adverse Event Report: COOK IRELAND LTD EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED; MQR STENT, COLONIC METALLIC EXPANDABLE

Model Number G48029

Device Problem Mechanical Problem (1384)

Patient Problems Death (1802); Bowel Perforation (2668)

Event Type  Death  

Manufacturer Narrative

Pma/510(k) # = k163468.(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

Stent was implanted and 4 days later, a perforation of colon was found.Patient died."as per complaint form": stent placed without any issues.Four days later, a perforation in the colon occurred; patient passed away.I am waiting for more detailed info from dr (b)(6), which will be forwarded as soon as i received them.

Manufacturer Narrative

Pma/510(k) # = k163468.(b)(4).Information pertaining to section as follows: importer site contact and address: (b)(4).Importer site establishment registration number: (b)(4).Device evaluation: the evo-25-30-6-c stent of lot number c1460579 was unavailable for evaluation.With the information provided a document based investigation was carried out.The patient had the following pre-existing conditions: as stated in the physicians letter- ¿malignom suspicious colon-cockade in proximal sigma - no further diagnostic, due to wish for palliative therapy - implantation of a metalstent in sigma on (b)(6) 2018 hypochrome, microzytäre anemia, hb 6.3 g/dll; dd (differential diagnosis) anemia of chronic disease - exclusion of upper gi bleeding by an egd on (b)(6) 2018 - transfusion of 2 eks (red blood cell concentrate) without complications (increase of hb to 8.3 g/dll) slightly active b-gastritis in antrum and corpus (egd from (b)(6) 2018) - no indication for eradication right sided cardial decompensation (nyha iii-iv) known reduced systolic function (hferf, lvef ca 40%) by unknown etiology and high grade diastolic dysfunction ulcera cruris right side coronary2- vessel disease with - 60%, proximal rd stenosis and 50% long distance stenosis in segment 2/3 of rca - no need for intervention of the stenosis valvular heart disease - insufficiency of aortic valve i-ii° - insufficiency of mitral i-ii° moderate mitral valve insufficiency ectasia of aorta descendens (aorta root 40mm) permanent vh fibrillation chronic kidney insufficiency in stadium iiib according kdigo (06/18) status after pneumonia, basal right side, 9/16 hypertensive coronary heart disease¿ root cause: there was no device returned for investigation, and no images available for review, therefore a definite root cause could not be determined.However, as per the instructions for use, ((b)(4)), potential complications section: ¿those associated with gi endoscopy include, but are not limited to: perforation, haemorrhage, aspiration, respiratory depression or arrest, cardiac arrhythmia or arrest.¿ document review: prior to distribution all evo-25-30-6-c devices are subject to visual inspection and functional checks to ensure device integrity.There inspections and functional checks are outlined in internal procedures in place at cirl.A review of relevant manufacturing records for lot c1460579 revealed no discrepancies that could have contributed to this complaint issue.Summary: there is no evidence to suggest that this event did not occur, therefore the complaint is confirmed based on customer testimony.Patient passed away on (b)(6) 2018 at 17:56 on the ward.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Stent was implanted and 4 days later a perforation of colon was found.Patient died "as per complaint form": stent placed without any issues.The 4 days later a perforation in the colon occured; patient passed away.I am waiting for more detailed infos from dr (b)(6), which will be forwarded as soon as i received them.

• Brand Name: EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED
• Type of Device: MQR STENT, COLONIC METALLIC EXPANDABLE
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: heather ryan ; o halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 7831695
• MDR Text Key: 118708935
• Report Number: 3001845648-2018-00407
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480299
• UDI-Public: (01)10827002480299(17)200307(10)C1460579
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2018

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 Expiration Date: 03/07/2020
• Device Model Number: G48029
• Device Catalogue Number: EVO-25-30-6-C
• Device Lot Number: C1460579
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/30/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 08/02/2018
• Supplement Dates FDA Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/07/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death