MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number UNK476

Device Problems Partial Blockage (1065); Migration or Expulsion of Device (1395); Positioning Problem (3009); Appropriate Term/Code Not Available (3191)

Patient Problem Bacterial Infection (1735)

Event Date 06/20/2015

Event Type  Injury  

Manufacturer Narrative

The mean age of patients undergoing stent insertion in this study was 65.4 +/- 12.0 years.The 16 men and 7 women underwent stenting with the wallflex duodenal stent during this study.The specific upn and lot number were not reported; therefore, the manufacture date and expiration date are unknown.However, it was noted that 23 patients had uncovered nitinol duodenal wallflex stents with a body diameter of 22 mm and flare of 27 mm of varying lengths - 60,90 and 120 mm.(b)(4).Journal article: isaac soo, et al."palliation of malignant gastric outlet obstruction with simultaneous endoscopic insertion of afferent and efferent jejunal limb enteral stents in patients with recurrent malignancy" springer science+business media new york 2015 30:521-525.Doi http://dx.Doi.Org/10.1007/s00464-015-4234-6.The devices have not been received for analysis; therefore failure analysis of the complaint devices could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

Boston scientific corporation became aware of multiple events through the article ¿palliation of malignant gastric outlet obstruction with simultaneous endoscopic insertion of afferent and efferent jejunal limb enteral stents in patients with recurrent malignancy¿ written by isaac soo, et al.According the literature, the aim of the article was to describe the efficacy and safety of simultaneous endoscopic insertion of self-expanding metal stents into the afferent and efferent jejunal limbs in patients with gastric outlet obstruction (goo) of post-surgical anatomy for palliation of recurrent malignancy.The wallflex duodenal stent was used to treat 23 patients; these patients were identified from an endoscopic database at a specialized cancer center between september 2007 and march 2014.Of the 23 patients, 13 had pancreas adenocarcinoma, 9 had gastric adenocarcinoma and 1 had gallbladder adenocarcinoma.One patient underwent stent revision for management of an obstructing food bolus that was lodged in the afferent jejunal limb stent.The food bolus was removed using a roth net retrieval device and a wallstent was inserted coaxially within the efferent jejunal limb to facilitate preferential food movement into the efferent jejunal limb, as it was suspected that the afferent limb prosthesis was blocking the efferent jejunal limb stent.The patient improved after reintervention and no further reintervention was required.Eight patients required re-intervention post stent placement.Five of the eight patients had stent revisions; 1 insertion of another wallflex stent coaxially within preexisting efferent stent obstructed by tumor ingrowth, 2 insertions of another wallflex stent coaxially into preexisting afferent/efferent stents obstructed from tumor overgrowth, 1 afferent limb enteral stent length trimmed/shortened with argon plasma coagulation (apc) due to obstruction of food passage into efferent stent, and 1 removal of afferent limb enteral stent that had migrated into gastric body.Four of the five patients did not require further intervention but one patient received apc treatment of tumor overgrowth of stent 5 days post revision.Two patient¿s had a combination of drainage peg and feeding pej, though stents were patent at the time of peg/pej insertion.One patient had bacteremia that was attributed to obstruction of the afferent jejunal limb stent by an impacted food bolus felt related to afferent limb stent compression/blockage of the efferent limb stent.It was suspected that afferent stent was malpositioned blocking the efferent limb stent.The patient was treated with antibiotics, food bolus disimpaction and stent revision.Subsequently the patient was able to tolerate oral nutritional intake.The article did not provide any further information regarding these patients.If any additional information is received, a supplemental report will be filed.

• Brand Name: WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MOD M00565010
• 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: 6412896
• MDR Text Key: 70253779
• Report Number: 3005099803-2017-00793
• Device Sequence Number: 1
• Product Code: MUM
• 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,litera
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/20/2017

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: UNK476
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2017
• Initial Date FDA Received: 03/17/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention