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

Model Number M00565010

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

Patient Problems Perforation (2001); No Code Available (3191)

Event Date 10/06/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) - (no code available) has been used to capture the report of the patient undergoing surgical intervention with gastro jejunal derivation and duodenal stump suture.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 october 08, 2017 that wallflex duodenal stent was implanted to treat an intra-duodenal stenosis going up to the duodenal bulb with occlusive syndrome caused by a pancreatic tumor during a duodenal stent placement procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.On (b)(6) 2017, the physician successfully implanted a wallflex duodenal stent.Reportedly, the stent placement had a ¿very good efficacy on the occlusive syndrome with vomiting interruption of j0¿.On (b)(6) 2017, 10 days post procedure, the patient presented with hyperthermia associated with vomiting and abdominal pains.The physician performed a scan; low pressure pneumoperitoneum and duodenal perforation were noted at the proximal end of the stent.In the physician¿s assessment, the stent contributed to the perforation.On (b)(6) 2017, a non-anastomosis gastrojejunal derivation and duodenal stump suture surgery was performed to treat the perforation.The stent remains implanted.The patient¿s current condition was reported to be stable but ¿still fragile¿.

• 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: 6994278
• MDR Text Key: 90839318
• Report Number: 3005099803-2017-03165
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 10/08/2017

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: 08/23/2018
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 19627424
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2017
• Initial Date FDA Received: 11/01/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2016
• 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