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

Model Number M00565100

Device Problems Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted in the rectum during a colon stent deployment procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a malignant stricture as a bridge to surgery (bts).Reportedly, the patient's anatomy was tortuous.During the procedure, the physician deployed the stent, but noted on endoscopic image that a stent wire was protruding through the delivery system.The physician pulled the delivery system and the stent was released.The proximal wires tore and the physician then attached the deformed wires to the proximal end of the stent using clips.The physician noted that the stent was fully deployed and expanded but was not deployed at its intended location.The stent remains implanted.The physician reported there was no damage noted to the delivery system.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 good.

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Reported event of stent placement / positioning problem.Reported event of stent broken.The complainant indicated that the device remains implanted 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.

• Brand Name: WALLFLEX? COLONIC
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 4363748
• MDR Text Key: 5285015
• Report Number: 3005099803-2014-04040
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/16/2016
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 17053312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2014
• 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
• Patient Outcome(s): Required Intervention