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

Device Problems Obstruction of Flow (2423); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2010

Event Type  Injury  

Manufacturer Narrative

Date of event: approximated based on the month and year the first procedures were performed.The complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.The initial reporter's facility name is (b)(6).Report source: literature source: matsumoto, t., hino, k., terasawa, h., nakasya, a., uesugi, k., nishide, n., kajiwara, t., asagi, a., nishina, t., nasu, j., hori., s., nadano, s., ishii, h.Consideration of endoscopic stenting for gastroduodenal stenosis due to malignancy: through comparison with gastrojejunostomy.Palliative care research 2016; 11(2): 166-73.(b)(4).

Event Description

Boston scientific became aware of events through the article "consideration of endoscopic stenting for gastroduodenal stenosis due to malignancy: through comparison with gastrojejunostomy" by dr.Toshihiko matsumoto, et al.Both wallflex duodenal stents and non-boston scientific (taewoong niti-s) duodenal stents were used during the study and the stents were implanted to treat gastroduodenal stenosis due to unresectable malignancy during gastroduodenal stenting procedures performed between april 2010 and april 2015.25 patients were including in the stenting group of the study, with 6 implanted with wallflex duodenal stents and the other 19 implanted with non-boston scientific duodenal stents.According to the literature, two stents were noted to be occluded at 108 and 188 days post stent placement and the stents were repositioned.Another stent was found to have migrated 237 days post stent placement.It is unknown how the stent migration was resolved.Note: it is unknown whether the boston scientific wallflex duodenal stents or the non-boston scientific duodenal stents encountered the reported events.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14251995
• MDR Text Key: 290447608
• Report Number: 3005099803-2022-02210
• Device Sequence Number: 1
• Product Code: MUM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2022
• 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