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

Model Number M00565100

Device Problems Break (1069); Occlusion Within Device (1423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/10/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex colonic stent was used in the colon during a stent implantation procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 2-3cm recurrent lesion.Reportedly, the patient's anatomy was not tortuous.During the procedure, there were no issues with the stent implantation.However, it was observed through scope that one of the loops at the anal side was broken.The physician was concerned that it may cause perforation in the intestinal tract, so the physician cut off the broken loop.The stent remains implanted and the patient is being monitored.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 fine.

Manufacturer Narrative

(b)(4) 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.

Manufacturer Narrative

The device was not returned for analysis; however images received that were taken during the procedure on (b)(6) 2014 were evaluated.The images of the device showed that a proximal wire weld was broken off and some stent cells were uneven/changed.The images and customer¿s concerns were reviewed by a member of the design assurance team and it was highlighted that weld failures do not result in a decrease in radial force.The welds were provided for the purpose of terminating the stent wire in an atraumatic manner.It was confirmed that a stent could collapse if the stent wires were pulled with significant force; however, this would not occur using the delivery system but may happen in an attempt to reposition a stent.Stent repositioning post deployment is contraindicated in the directions for use (dfu).Given the event description and condition of the returned device, there isn't enough information to determine a probable root cause.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.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 that a wallflex colonic stent was used in the colon during a stent implantation procedure performed on (b)(6) 2014.According to the complainant, the stent was implanted to treat a 2-3cm recurrent lesion.Reportedly, the patient's anatomy was not tortuous.During the procedure, there were no issues with the stent implantation.However, it was observed through scope that one of the loops at the anal side was broken.The physician was concerned that it may cause perforation in the intestinal tract, so the physician cut off the broken loop.The stent remains implanted and the patient is being monitored.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 fine.Correction; additional information received november 19, 2014.According to the complainant, photos taken during the stent placement procedure on (b)(6) 2014 showed that some stent cells were uneven/changed.During an endoscopy procedure performed on (b)(6) 2014, the physician noted that the stent was obstructed at the distal/oral side of the stent.

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a wallflex colonic stent was used in the colon during a stent implantation procedure performed on (b)(6), 2014.According to the complainant, the stent was implanted to treat a 2-3cm recurrent lesion.Reportedly, the patient's anatomy was not tortuous.During the procedure, there were no issues with the stent implantation.However, it was observed through scope that one of the loops at the anal side was broken.The physician was concerned that it may cause perforation in the intestinal tract, so the physician cut off the broken loop.The stent remains implanted and the patient is being monitored.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 fine.(b)(4).According to the complainant, photos taken during the stent placement procedure on (b)(6), 2014 showed that some stent cells were uneven/changed.During an endoscopy procedure performed on (b)(6), 2014, the physician noted that the stent was obstructed at the distal/oral side of the stent.

• 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: 4291986
• MDR Text Key: 22028174
• Report Number: 3005099803-2014-03820
• 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,Followup,Followup
• Report Date: 11/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2016
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0017027650
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2014
• 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
• Patient Age: 53 YR