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

Model Number M00555870

Device Problem Activation Failure (3270)

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

Event Date 01/19/2018

Event Type  Death  

Manufacturer Narrative

(b)(4).The complainant indicated that the device is 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 january 22, 2018 that a wallflex duodenal soft uncovered stent was implanted from the descending part of the duodenum to the antrum of the stomach with the flared end fully inside the stomach to treat a 1 to 2 cm stenosis during a duodenal stent placement procedure performed on (b)(6) 2018.Reportedly, the stenosis was due to metastasis of the patient¿s lung cancer and was resulting in vomiting, the physician deployed the stent to reduce the vomiting.The patient¿s anatomy was moderately tortuous, was not dilated prior to stent placement and the intended stent placement site was in a significant bend.On (b)(6) 2018, the physician successfully implanted the wallflex duodenal soft uncovered stent.After placement on (b)(6) 2018 the stent dilation was reportedly not good.On (b)(6) 2018, no expansion was noted with the stent and patient still presented with vomiting so a stomach tube was inserted.On (b)(6) 2018, the patient presented with a fever and medication was administered.On (b)(6) 2018, a computed tomography (ct) scan was performed to check the stent and noted that the stent was not fully expanded.A blood test was taken and noted an inflammatory response.On (b)(6) 2018, the inflammatory response was noted to have worsened and a ct scan was performed which showed the stent had expanded but free air was noted.Perforation was found at the anterior wall of the stomach, near the ostium pyloricum, at the non-flared section of the stent.In the physician¿s assessment, the stent¿s expansion may have contributed to the perforation.Surgery to treat the perforation was considered, however, a conservative medical approach was followed due to the patient¿s condition (patient was non-ambulatory performance status 4).Meropenem hydrate(antibiotic) and thrombomodulin alfa were administered to the patient.On (b)(6) 2018, the patient expired due to sepsis and in the physician¿s assessment the sepsis was a result of the perforation.

• 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: 7273084
• MDR Text Key: 100150666
• Report Number: 3005099803-2018-00240
• 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: 01/22/2018

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 Expiration Date: 09/22/2019
• Device Model Number: M00555870
• Device Catalogue Number: 5587
• Device Lot Number: 21166356
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2018
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/25/2017
• 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: 83 YR
• Patient Weight: 51