MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ? DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565020

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2014

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted in the duodenum during a duodenal stenting procedure performed on (b)(6) 2014.According to the complainant, this was to treat a lesion due to duodenal cancer.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, the physician began to deploy the stent but the handle almost detached from the catheter 1cm away from full deployment.The stent could no longer be reconstrained or deployed further.Using the two-channel scope, the physician used a forcep through the second working channel to pull the stent off the delivery system, deploying the stent completely.The wallflex enteral duodenal stent remains implanted.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

(b)(4) stent partially deployed.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.

Manufacturer Narrative

A visual examination of the returned device noted that the stent had been deployed and the stent was not returned.The outer sheath was retracted and kinked distally to the distal handle.The stainless steel handle was severely bent and was almost broken.During analysis, when an attempt was made to move the outer sheath along the shaft, the stainless steel shaft completely broke and the outer sheath detached from the distal handle.No issues were noted when the outer sheath was dissected longitudinally.The noted damages to the returned device is consistent with excessive force being applied during deployment and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.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 enteral duodenal stent was implanted in the duodenum during a duodenal stenting procedure performed on (b)(6) 2014.According to the complainant, this was to treat a lesion due to duodenal cancer.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the procedure, the physician began to deploy the stent but the handle almost detached from the catheter 1cm away from full deployment.The stent could no longer be reconstrained or deployed further.Using the two-channel scope, the physician used a forcep through the second working channel to pull the stent off the delivery system, deploying the stent completely.The wallflex enteral duodenal stent remains implanted.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 ? DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• 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: 4358772
• MDR Text Key: 5204346
• Report Number: 3005099803-2014-03990
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: SG
• PMA/PMN Number: K062750
• 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
• Report Date: 12/02/2014

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: 05/16/2015
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0016098946
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 12/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2013
• 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