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

Catalog Number EVO-25-30-8-C

Device Problem Activation Failure (3270)

Patient Problem Surgical procedure, additional (2564)

Event Type  Injury  

Event Description

A (b)(6) woman presented with a large bowel obstruction of the sigmoid colon (at 2 different levels, secondary to metastatic cervical cancer).Patient was stented with a boston sci ultraflex 25x87mm (for the distal obstruction) anda cook evolution 25mmx80mm (for the proximal one).After 48 hours the evolution stent had not expanded fully.The patient was returned to the operating room for re-stenting and ballooning.The complaint information received indicated the patient was doing well after the additional procedure to re-stent, no further adverse effects to the patient have been reported as occurring.

Manufacturer Narrative

The device was not available to be returned for evaluation; therefore a document based investigation was carried out.The customer complaint could be confirmed based on the customers testimony and images provided.As the device has not been returned the cause of the complaint could not be conclusively determined.Clinical feedback received indicated that in really tight strictures a greater time period than 48 hours may be required for a stent to expand.Complaint information received indicated large bowel obstruction of the sigmoid colon at 2 different levels, secondary to metastatic cervical cancer as a pre-existing condition of the patient.A review of the relevant manufacturing records for the evo device could not be performed as the lot number of the complaint device was not provided.Prior to distribution evolution devices are subjected to a visual inspection and functional checks to ensure device integrity.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; limerick ; EI
• Manufacturer Contact: sinead quaid, sr specialist ; 61334440
• MDR Report Key: 4584909
• MDR Text Key: 5338420
• Report Number: 3001845648-2015-00044
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• PMA/PMN Number: K113510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/05/2015

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 Catalogue Number: EVO-25-30-8-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/04/2015
• Initial Date FDA Received: 03/06/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 60 YR