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

Model Number M00565100

Device Problem Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Reported event of stent kinked.The device has been received for analysis; however, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(4) 2016 that a wallflex enteral colonic stent was used in the colon during colonic stent placement procedure performed on (b)(6) 2016.According to the complainant, the stent was used to treat a stricture caused by colon cancer.Reportedly, the patient's anatomy was tight.During the procedure, the physician was able to fully deploy the wallflex colonic stent.However, the physician attempted to reposition the stent and the stent became deformed and kinked.The stent was removed from the patient with biopsy forceps and the procedure was not completed due to this event.The physician is planning to place another stent in the desired location.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

A deployed wallflex enteral colonic stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent deployed and damaged, with a guidewire back loaded into the device.No issues were found with the device catheter.No ptfe delamination was seen post-dissection.The stent was severely kinked and flattened.No other issues were identified during the product analysis.The noted damages to the returned device are likely due to anatomical or procedural factors such as tortuous/tight anatomy encountered during procedure, performance of the device was limited.Therefore, the most probable root cause for this complaint is operational context.Aa 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) 2016 that a wallflex enteral colonic stent was used in the colon during colonic stent placement procedure performed on (b)(6) 2016.According to the complainant, the stent was used to treat a stricture caused by colon cancer.Reportedly, the patient's anatomy was tight.During the procedure, the physician was able to fully deploy the wallflex colonic stent.However, the physician attempted to reposition the stent and the stent became deformed and kinked.The stent was removed from the patient with biopsy forceps and the procedure was not completed due to this event.The physician is planning to place another stent in the desired location.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: 5470895
• MDR Text Key: 39423429
• Report Number: 3005099803-2016-00479
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• 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: 02/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2016
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0017104372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2014
• 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