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

Model Number M00565020

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Perforation (2001)

Event Date 07/21/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).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.

Event Description

It was reported to boston scientific corporation on (b)(6) 2016 that a wallflex enteral duodenal stent was implanted in the gastroduodenal area during a stent placement procedure performed on (b)(6) 2016.The stent was implanted to treat a stricture due to stomach cancer.There were no issues reported during initial stent placement.On (b)(6) 2016, the patient presented with a stomachache.A ct scan was performed and it was noted that the stent had straightened and perforated the right lobe of the liver.On (b)(6) 2016, a second ct scan was performed and confirmed free air inside the abdominal cavity.It was noted that the stent poked into the abdominal cavity.The perforation was located at the distal end of the stent.According to the physician, the cause of the perforation was unknown.Due to the patient's liver metastasis and overall condition, the physician decided not to perform any surgery or endoscopy for confirmation.Treatment for the perforation included antibiotics and abstention from food.

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5884506
• MDR Text Key: 52380185
• Report Number: 3005099803-2016-02364
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• 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
• Report Date: 07/27/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/28/2018
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 18862598
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/27/2016
• Initial Date FDA Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2016
• 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: 76 YR