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

Model Number M00565030

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/21/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Event of stent positioning / placement problem.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 on (b)(6) 2015, that a wallflex duodenal stent was to be used in the duodenum during a duodenal stenting procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 5cm malignant lesion in the duodenum d1 and pylorus.Reportedly, the patient's anatomy was not pre dilated.During the procedure, the physician deployed the stent without issues.However, it was noted that the stent had migrated two minutes after deployment, while the delivery system was being removed.The stent was removed from the patient with foreign body biopsy forceps and the procedure was completed with another wallflex duodenal stent.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 wallflex enteral duodenal stent delivery system was received for evaluation.Visual examination of the returned device found out that the stent had been deployed and was not received for analysis.The blue outer sheath was bent in multiple places and there was slight buckling of the clear outer sheath at the distal end.This damage is consistent with the application of excessive force.No issues were found with the tip of the inner sheath, and the clear outer sheath sat flush with the inner distal tip when the delivery system was fully closed.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 labeling review was performed and, from the information available, it was uncertain if this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on (b)(6) 2015, that a wallflex duodenal stent was to be used in the duodenum during a duodenal stenting procedure performed on (b)(6) 2015.According to the complainant, this was to treat a 5cm malignant lesion in the duodenum d1 and pylorus.Reportedly, the patient's anatomy was not pre dilated.During the procedure, the physician deployed the stent without issues.However, it was noted that the stent had migrated two minutes after deployment, while the delivery system was being removed.The stent was removed from the patient with foreign body biopsy forceps and the procedure was completed with another wallflex duodenal stent.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; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5294392
• MDR Text Key: 33417420
• Report Number: 3005099803-2015-03491
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/21/2015

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: 05/05/2017
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0017958991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2015
• Initial Date FDA Received: 12/14/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2015
• 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: 65 YR
• Patient Weight: 62