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

Model Number M00565030

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/18/2014

Event Type  malfunction  

Manufacturer Narrative

Reported event of stent partially deployed.The device has not been received for analysis.Upon receipt and 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 that a wallflex enteral duodenal stent was used in the duodenum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was being used to treat a malignant stricture in the first part of the duodenum about 4 cm from the pyloric ring.Reportedly, the patient¿s anatomy was not tortuous and there was no difficulty during advancing the stent through the patient anatomy.During the procedure, the physician attempted to deploy the stent, difficulty was noted and the stent was only able to be deployed 3cm.During the attempted deployment, the handle detached from the outer sheath and the stent was removed from the patient partially deployed.The procedure was not completed due to this event.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

Investigation results: a visual analysis of the returned device found out that the stent was fully mounted onto the delivery system.The investigator noted that the distal handle had detached from the dark blue outer sheath and the stainless steel tube was kinked 10mm distal to the distal handle.This type of damage is consistent with excessive force exerted on the catheter during deployment.The investigator was unable to advance and retract the outer sheath by hand.A visual and tactile examination found that the dark blue outer sheath was severely kinked and accordioned across its length.The shaft was dissected at the proximal end of the clear outer sheath.The investigator noted that it was then possible to advance and retract the inner.The stent and the inner were visually and microscopically examined and no issues were noted with their profiles and the proximal end of the inner was withdrawn from the outer sheath and it was noted that it was kinked at various positions along its length.The blue section of the outer sheath was dissected longitudinally and it was noted that some of the polytetrafluoroethylene (ptfe) coating had partially peeled away from the inside of the outer sheath.No other issues were identified during the product analysis.The noted damages were likely due to procedural or anatomical factors encountered during the procedure such as tortuous anatomy or maneuvering of the device.Therefore, the most probable root cause for this complaint 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 used in the duodenum during a stent placement procedure performed on (b)(6) 2014.According to the complainant, the stent was being used to treat a malignant stricture in the first part of the duodenum about 4 cm from the pyloric ring.Reportedly, the patient¿s anatomy was not tortuous and there was no difficulty during advancing the stent through the patient anatomy.During the procedure, the physician attempted to deploy the stent, difficulty was noted and the stent was only able to be deployed 3cm.During the attempted deployment, the handle detached from the outer sheath and the stent was removed from the patient partially deployed.The procedure was not completed due to this event.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: 4078415
• MDR Text Key: 19454760
• Report Number: 3005099803-2014-03051
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 08/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/23/2015
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 16478612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2014
• Initial Date FDA Received: 09/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/12/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/25/2013
• 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 Age: 42 YR
• Patient Weight: 56