MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565050

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was contaminated and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that a wallflex colonic stent was used in the sigmoid colon during a colonic stenting procedure performed on (b)(6) 2015.According to the complainant, the stent was placed as a bridge to surgery to treat a 3cm colonic obstructing lesion caused by colonic cancer.Reportedly, the patient's anatomy was not tortuous.There was no visible damage noted to the stent prior to the procedure.During the procedure, following a colonoscopy, the wallflex colonic stent was deployed without any issues.After the stent had been completely deployed, the physician noted that part of the distal loop was broken.In order to prevent movement of the sharp/broken wire of the stent, the physician used hemostatic clips to fix the wire in place.During the week of (b)(6) 2015, the physician noted that the obstruction had been adequately relieved and planned the colonic obstruction removal surgery.During the planned excision surgery for the colonic obstruction, the physician removed the stent together with the desired portion of the patients intestine.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

The device was not returned for analysis.However, photos were provided by the physician which confirmed that the stent was damaged.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the condition of the returned device and the evaluation conducted, a definitive root cause for the reported failure could not be determined; therefore, the root cause classification is undeterminable.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015 that a wallflex colonic stent was used in the sigmoid colon during a colonic stenting procedure performed on (b)(6) 2015.According to the complainant, the stent was placed as a bridge to surgery to treat a 3cm colonic obstructing lesion caused by colonic cancer.Reportedly, the patient's anatomy was not tortuous.There was no visible damage noted to the stent prior to the procedure.During the procedure, following a colonoscopy, the wallflex colonic stent was deployed without any issues.After the stent had been completely deployed, the physician noted that part of the distal loop was broken.In order to prevent movement of the sharp/broken wire of the stent, the physician used hemostatic clips to fix the wire in place.During the week of (b)(6) 2015 the physician noted that the obstruction had been adequately relieved and planned the colonic obstruction removal surgery.During the planned excision surgery for the colonic obstruction the physician removed the stent together with the desired portion of the patients intestine.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLFLEX¿ COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5220059
• MDR Text Key: 30999722
• Report Number: 3005099803-2015-03085
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2015

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 Expiration Date: 07/16/2017
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0018205554
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2015
• Initial Date FDA Received: 11/12/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2015
• 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: 36 YR