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

Model Number G48028

Device Problems Break (1069); Deformation Due to Compressive Stress (2889)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 05/18/2020

Event Type  malfunction  

Manufacturer Narrative

510 k #: k163468.Investigation is still pending.A follow up mdr will be submitted to include the investigation conclusions.

Event Description

During placement of the stent, during deployment, the tech began to trigger squeeze and squeezed it 3 times smoothly.Upon the 4th trigger squeeze, the handle broke and when it broke, the handle cracked and the cable broke at the sheath and the handle.The stent was beginning to exit the introducer at this time.The device and stent were withdrawn from the scope and another of the same device but different size was used to complete the procedure successfully with no issues.There was no harm to the patient and no interventional procedures needed.

Event Description

During placement of the stent, during deployment, the tech began to trigger squeeze and squeezed it 3 times smoothly.Upon the 4th trigger squeeze, the handle broke and when it broke, the handle cracked and the cable broke at the sheath and the handle.The stent was beginning to exit the introducer at this time.The device and stent were withdrawn from the scope and another of the same device but different size was used to complete the procedure successfully with no issues.There was no harm to the patient and no interventional procedures needed.Patient outcome: did any unintended section of the device remain inside the patient¿s body? no.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.Did the product cause or contribute to the need for additional procedures? no.Has the complainant reported any adverse effects on the patient due to this occurrence? no.Patient/event info - notes: 1.1.1 at what stage of the procedure did the complaint occur? during stent placement 1.1.2 what endoscope type and channel size was used? olympus 3.7.1.1.3 what was the position of the elevator? na.1.1.4 details of the wire guide used (diameter, type, make)?.035 600 cm tracer metro wire 1.1.5 did any part of the stent contact the patient¿s anatomy when the complaint occurred? only the introducer.1.1.6 how long was the stent in the patient by the time this complaint occurred? na stent was not deployed.1.1.7 for devices where the ifu states for longer term patency has not been established, was periodic evaluation complete and how often? na.1.4.1 did the product fail during stent deployment or recapture? 1.4.2 was the directional button pressed during use? it was in the forward deploy direction; however, the tech was inexperienced and the dm was watching the screen and not the tech's hand.The tech said you could describe the handle and "tight" the device was immediately placed in biobag; the button should be checked by cook medical investigation.1.4.3 was any part of the stent observed in contact with the patient¿s anatomy at the time of failure? only the introducer.1.4.4 was the yellow marker kept in view during deployment? yes.1.4.5 are images of the device or procedure available? no.Info received on 09jun2020: - ar 15jun2020.Stricture information: 1.What was the length and diameter of the stricture? unknown.2.Where was the stricture located in the body? sigmoid.3.Was there resistance felt passing wire guide through stricture? no.4.Was there resistance felt passing the evolution through stricture? no.5.Was the stricture dilated before stent placement? no.Questions related to during insertion into patient: 1.Was the product inspected for kinks or damage before use? yes.2.Was resistance felt during insertion into patient? if yes, at what point? no.Questions related to during stent placement: 1.Did the product fail during stent deployment or recapture? deployment.Questions related to during introducer withdrawal: 1.Was final stent placement confirmed using endoscopy / fluoroscopy? if yes, what was used? 2.Did the stent open sufficiently to allow withdrawal of introducer safely? n/a.3.Was the safety wire fully removed before removing the delivery system? n/a.4.Did any part of the product snag/get caught with the stent when removing the delivery system? no.5.Are images of the device or procedure available? no.Questions related to during stent repositioning/removal: 1.What instrument was used for stent repositioning / removal? forceps, snare.Was the lasso (suture) loop used during repositioning n/a.

Manufacturer Narrative

Pma/510(k)#: k163468.Device evaluation: the evo-25-30-8-c device of lot number c1707404 involved in this complaint device involved in this complaint was returned for evaluation, with the original packaging.With the information provided, a physical examination and document based investigation was conducted.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on the 09th july 2020.The returned device lab findings and observations can be referred through the attached files.In summary the following results were observed in the lab evaluation: outer sheath was observed broken.Handle was actuating fine but unable to deploy the stent due to break.Handle was opened and no other defects observed.Documents review including ifu review: prior to distribution all evo-25-30-8-c 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.(d00059776(qsi0975) rev 031, d00052106 (prd0281) rev 015, d00055312 (fqc0172) rev 015).A review of the manufacturing records for evo-25-30-8-c device of c1707404 lot number did not reveal any discrepancies that could have contributed to this issue.There is no evidence to suggest that this issue affects the entire lot #c1707404; upon review of complaints this failure mode has not occurred previously with this lot #c1707404.The instructions for use (b)(4) 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".There is no evidence to suggest that the customer did not follow the instructions for use.Image review: n/a.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 the torturous patient anatomy.It is possible that during deployment tortuous path may have caused a build-up of pressure resulting in the flexor break.Summary: according to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaint is confirmed as the failure was verified in the laboratory.Complaints of this nature will continue to be monitored for potential emerging trends.

• 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: 10155075
• MDR Text Key: 199106732
• Report Number: 3001845648-2020-00353
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 10827002480282
• UDI-Public: (01)10827002480282(17)220211(10)C1707404
• 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
• Report Date: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: G48028
• Device Catalogue Number: EVO-25-30-8-C
• Device Lot Number: C1707404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2020
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2020
• Event Location: Hospital
• Date Manufacturer Received: 05/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1