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

Model Number M00555880

Device Problem Migration or Expulsion of Device (1395)

Patient Problems Aspiration/Inhalation (1725); Death (1802); Pneumonia (2011)

Event Date 11/16/2017

Event Type  Death  

Manufacturer Narrative

Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to provide the 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 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) 2017 that a wallflex duodenal soft uncovered stent was implanted without issue on (b)(6) 2017 in reverse c-shape in from the duodenum¿s horizontal leg passing through the treitz.The stent was implanted to treat a 4 cm external pressure drainage stenosis caused by pancreatic tail cancer.Reportedly, the patient¿s anatomy was tortuous.On (b)(6) 2017, the patient was symptomatic, which prompted the physician to check the stent.The stent was found to have distally migrated beyond the duodenal stricture to the anal side.Per the physician ¿it was possible that stent radial force was not good and the stent migrated after implant.Or it was possible that the stricture is soft and the stent migrated due to peristaltic activity¿.On the same day, the patient expired due to aspiration pneumonia.The physician stated the patient was at an old age.Reportedly, the physician stated the aspiration was not caused by the stent but could not ¿deny the relationship between the stent and the aspiration pneumonia completely¿.

• 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: 7097565
• MDR Text Key: 94162661
• Report Number: 3005099803-2017-03718
• 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: 11/16/2017

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M00555880
• Device Catalogue Number: 5588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2017
• Initial Date FDA Received: 12/07/2017
• 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