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

Model Number M00565100

Device Problems Migration or Expulsion of Device (1395); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex colonic stent was implanted in the colon during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted treat a stenosis as a bridge to surgery.During the procedure, the stent was difficult to deploy; however, the stent was able to be deployed and successfully expanded.Computed tomography (ct) was performed and it was noted that the side of the stent wire on the anus side was broken.Endoscopy then showed a part of the wire weld was broken.The physician put the broken wires together to shape into a loop and completed the procedure.The patient's condition at the conclusion of the procedure was reported to be good.In (b)(6), during a scheduled surgery, the physician noted that the stent had migrated to the anus side of the stricture.The tumor and the stent were removed.According to the physician, the broken wire weld resulted in decreased radial force leading to the stent migration.There were no patient complications reported as a result of this event.Following the resection surgery the patient was noted to be in stable condition.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4) stent wires damaged.(b)(4) stent migration.The complainant indicated that the device was disposed 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: 4342009
• MDR Text Key: 5180654
• Report Number: 3005099803-2014-03962
• 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: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2016
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0017202733
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• 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