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 Death (1802); Unspecified Infection (1930); Perforation (2001)

Event Date 01/03/2014

Event Type  Death  

Event Description

It was reported to boston scientific corporation that a wallflex enteral duodenal stent was implanted during a stent placement procedure performed on (b)(6) 2013.According to the complainant, the stent was implanted as a palliative treatment of a 3 cm malignant gastroduodenal stricture due to advanced pancreatic cancer.No issues were noted during the procedure.Reportedly, the patient had chemotherapy prior to the stent placement procedure.On (b)(6) 2014, the patient complained of abdominal pain and a ct scan confirmed free air from a perforation around the site of the stent implantation.However, the specific site of the perforation was not identified.In the physician¿s assessment, it was not clear whether the stent caused the perforation.The physician chose to perform conservative observation of the perforation due to the patient¿s condition.Subsequently, the patient developed peritonitis and died on (b)(6) 2014.In the physician¿s assessment, it was possible that the peritonitis was due to the perforation; however, it was unable to be determined whether it was peritonitis carcinomatosis or perforative peritonitis.The physician also noted that the patient¿s pancreatic cancer was advancing.According to the physician, the cause of death was not determined and it was unknown whether the patient¿s death was related to the stent.

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date 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.

• 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: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3594926
• MDR Text Key: 19692018
• Report Number: 3005099803-2014-00648
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/09/2014

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?: No
• Device Operator: Health Professional
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/09/2014
• Initial Date FDA Received: 01/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 63 YR
• Patient Weight: 44