MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00555860

Device Problem Activation Failure (3270)

Patient Problems Unspecified Infection (1930); Inflammation (1932)

Event Date 05/18/2018

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the (b)(6).The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex duodenal soft uncovered stent has been implanted to treat a stenosis in the lower duodenum during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight.The patient had a history of prostate cancer and retroperitoneal neoplasm.According to the complainant, on (b)(6) 2018, during stent placement, an endoscopic clip was applied in the upper part of stenosis as a guide for the stent placement.The stent was successfully implanted in the duodenum overlapping the papilla.On (b)(6) 2018, 4 days post stent placement, the patient had developed cholangitis and pancreatitis, which were confirmed by blood sampling test.The stent was checked and noted to be in the desired location.However, the stent was not fully expanded.On (b)(6) 2018, a percutaneous transhepatic biliary drainage (ptbd) was performed to treat the patient's cholangitis and pancreatitis.The stent remains implanted.The patient is under follow-up observation.According to the physician, the stent placement position was related to the pancreatitis and the cholangitis.

• Brand Name: WALLFLEX¿ DUODENAL SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• 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: 7583885
• MDR Text Key: 110533449
• Report Number: 3005099803-2018-01915
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 05/18/2018

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 Model Number: M00555860
• Device Catalogue Number: 5586
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 06/08/2018
• 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): Required Intervention