MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565020

Device Problem Activation Failure (3270)

Patient Problem Reocclusion (1985)

Event Date 01/13/2019

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(6).(b)(4).According to the complainant, the suspect device 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) 2019 that a wallflex duodenal stent was implanted to treat a malignant duodenal stenosis during a duodenal stent placement procedure performed on (b)(6) 2019.The patient's anatomy was dilated prior to stent placement.Reportedly, the patient was diagnosed with pancreatic cancer and underwent a gastroenterostomy procedure prior to stent implantation.The anastomosis developed into a stenosis which caused the patient to be unable to eat and sometimes vomit.According to the complainant, on (b)(6) 2019, the wallflex duodenal stent was successfully implanted.The patient was able to drink a little water post stent placement, but still continued to vomit.After a couple days the patient could not drink water at all.On (b)(6) 2019, imaging was performed and confirmed a restenosis compressing the stent from the middle to the distal part of the stent.On (b)(6) 2019, the physician attempted a secondary expansion using a non-bsc balloon device; however, the balloon was unable to cross the lesion.Reportedly, no further treatment was performed at the family's request and the patient was discharged.The patient passed away after several days.In the physician's assessment, there was no relationship between the stent and the patient's death.Reportedly, the clinical cause of the patient's death was malignant tumor.

Manufacturer Narrative

Blocks a1, a2, a3, have been updated with additional information received on august 26, 2019.Block e1: initial reporter address 1: (b)(6).Block h6: problem code 3270 captures the reportable event of stent failed to expand.Block h10: according to the complainant, the suspect device 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.Block h11: blocks d4 (lot number and expiration date), e1 (initial reporter's name) and h4 have been corrected based on information received on august 26, 2019.

Event Description

It was reported to boston scientific corporation on august 08, 2019 that a wallflex duodenal stent was implanted to treat a malignant duodenal stenosis during a duodenal stent placement procedure performed on (b)(6) 2019.The patient's anatomy was dilated prior to stent placement.Reportedly, the patient was diagnosed with pancreatic cancer and underwent a gastroenterostomy procedure prior to stent implantation.The anastomosis developed into a stenosis which caused the patient to be unable to eat and sometimes vomit.According to the complainant, on (b)(6) 2019, the wallflex duodenal stent was successfully implanted.The patient was able to drink a little water post stent placement, but still continued to vomit.After a couple days the patient could not drink water at all.On (b)(6) 2019, imaging was performed and confirmed a restenosis compressing the stent from the middle to the distal part of the stent.On (b)(6) 2019, the physician attempted a secondary expansion using a non-bsc balloon device; however, the balloon was unable to cross the lesion.Reportedly, no further treatment was performed at the family's request and the patient was discharged.The patient passed away after several days.In the physician's assessment, there was no relationship between the stent and the patient's death.Reportedly, the clinical cause of the patient's death was malignant tumor.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8946033
• MDR Text Key: 156395085
• Report Number: 3005099803-2019-04314
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• 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
• Type of Report: Initial,Followup
• Report Date: 09/20/2019

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: 04/22/2020
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0022025158
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR