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

Model Number G48038

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Ulcer (2274)

Event Date 09/17/2018

Event Type  Injury  

Manufacturer Narrative

510(k) number: k163468.(b)(4).Investigation is still pending; a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Migration of stent on d1 after procedure (please refer to file for reference).Thank you.[repeat stenting required].

Event Description

Migration of stent on d1 after procedure.It was removed with grasping forceps.

Manufacturer Narrative

510(k) number: k163468.Cook ireland ltd (manufacturer) is submitting this report on behalf of cook medical incorporated (cmi)(importer).Exemption number: e2016031.Importer site contact and address: (b)(6).Cook medical incorporated (cmi) (b)(4).Importer site establishment registration number: (b)(4).Lab evaluation: the evo-25-30-10-c device of lot number c1463857 was not returned to cook ireland for evaluation, therefore a document based investigation was completed.Documents review including ifu review: prior to distribution all evo-25-30-10-c devices are subject to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.Upon review of complaints, this failure mode has not occurred previously with the lot number c1463857.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with the lot number c1463857.As per the instructions for use, ifu0052-10 which accompanies this device instructs the user to "visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use".Also, as per the instructions for use, both stent migration as well as ulcerations are described as potential complications in the ifu following the placement of this device.On review of the information provided, there is no evidence to suggest that the user did not follow the instructions for use.Image review: impression: the indication for placement of the evolution colonic controlled-release stent was advanced colon cancer and malignant obstruction.The complaint report states there was migration of the stent on day one after the procedure, but also makes note of anal ulcers caused by compression of the anal end of the stent.There are no fluoroscopic or endoscopic images available for the time of placement to better delineate the patients anatomy.The first x-ray image of the pelvis demonstrates the colonic stent positioned low in the pelvis with the distal margin of the stent extending below the pubic symphysis.There is a long segment of narrowing within the midportion of the stent, likely corresponding to the area of obstructing colonic mass.Given the low location of the distal stent margin, it is uncertain if this initial x-ray is pre or post the reported migration of the stent.On this image the distal margin of the stent likely terminates in the very distal rectum or potentially proximal anal canal.The follow-up x-rays demonstrate significant straightening of the mid-stent with less conspicuous narrowing in this region.The distal diameter of the stent increased dramatically, with a stacked appearance of the stent lattice.The diamond shaped interstices were now oriented perpendicular to the long axis of the stent, instead of being oriented parallel to the long axis of the stent, as initially seen.The area of narrowing presumably related to the colonic obstructing mass appears less stenotic on this exam, however, the stent still appears to be across the area of previously identified pathologic narrowing.The complaint report describes the pathologic stenotic length measuring approximately 5 cm in length and initial diameter of only 3 mm.Given the severe compression and distortion of the intrinsic stent configuration seen on the initial x-ray, potential colonic peristaltic activity contributed in the distal migration and "stacked appearance" of the distal portion of the stent.Given the muscle tone of the anal canal and the capacity of the rectum, the distal margin of the stent likely engaged at this transition point and would not advance through the anal canal to any significant extent.As peristaltic waves progressed through this area, and if the stenosis was fairly rigid, this resulted in the stent migrating forward causing the lattice to compress along the long axis of the stent.This process is commonly referred to ¿watermelon seeding¿ and is commonly seen with angioplasty balloons when trying to dilate a focal stenosis the balloon will want to move one direction or another if the balloon is not centered on the stenosis.This watermelon seeding can also be seen in with the use of wall stents, which have a similar single nitinol wire configuration as the evolution colonic stent.Furthermore, the complaint report states there were anal ulcers caused by compression of the anal end of the stent suggesting that the distal stent migration resulted in increased radial force and compression of the anal canal wall resulting in the ulcers.As the stent foreshortens, the radial force will increase.Both stent migration as well as ulcerations are described as potential complications in the ifu.Potentially, if a shorter stent was utilized or if the stent was positioned with the stenosis directly in the middle of the stent, this may have decreased the likelihood of this occurring.Alternatively, if the stent had greater radial force when the stent was significantly compressed, as seen initially, it may have better engaged with the tumor, preventing the migration.The stent was removed in its entirety and replaced with a new stent.There is no discussion regarding what size was chosen for the subsequent stent, nor if any recurrent issues were encountered with the second stent.Root cause review: the failure of ¿stent migration¿ which is listed as a potential complication was concluded from the available information.A definitive root cause could not be determined from the available information.A possible root cause determined from the image review could be attributed a process commonly referred to ¿watermelon seeding¿.When trying to dilate a focal stenosis the balloon will want to move one direction or another if the balloon is not centered on the stenosis.This watermelon seeding can also be seen in with the use of wall stents, which have a similar single nitinol wire configuration as the evolution colonic stent.Furthermore, the complaint report states there were anal ulcers caused by compression of the anal end of the stent suggesting that the distal stent migration resulted in increased radial force and compression of the anal canal wall resulting in the ulcers.Both stent migration as well as ulcerations are described as potential complications in the ifu.Summary: customer complaint is confirmed based the images received and on customer testimony.According to the information reported, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Migration of stent on d1 after procedure.It was removed with grasping forceps.

Manufacturer Narrative

510(k) number: k163468.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.

• 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
• MDR Report Key: 7978954
• MDR Text Key: 124144967
• Report Number: 3001845648-2018-00493
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480381
• UDI-Public: (01)10827002480381(17)200315(10)C1463857
• 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
• Report Date: 11/15/2018

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: 03/15/2020
• Device Model Number: G48038
• Device Catalogue Number: EVO-25-30-10-C
• Device Lot Number: C1463857
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/18/2018
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/21/2018
• Initial Date FDA Received: 10/18/2018
• Supplement Dates Manufacturer Received: 09/21/2018; 09/21/2018
• Supplement Dates FDA Received: 11/16/2018; 12/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 85 YR
• Patient Weight: 54