MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM; STENT, COLONIC, METALIC, EXPANDABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Disseminated Intravascular Coagulation (DIC) (1813); Hemorrhage/Bleeding (1888); Perforation (2001); Sepsis (2067); Peritonitis (2252); Insufficient Information (4580)

Event Date 10/01/2017

Event Type  Death  

Manufacturer Narrative

Block a2: age patient age is approximated based on the median age.Block b3: date of event: approximated on (b)(6) 2017, to (b)(6) 2020, as no event date was reported.Block d4: expiration date and h4: device manufacture date the upn and lot number of the wallflex duodenal stent was not specified in the article; therefore, the lot expiration and the device manufacture dates are unknown.Block d6a: implant date approximated to (b)(6) 2017, first date of the month of palliative stenting.Block g2: report source literature source: (b)(6), et al."gastroduodenal stenting with a flexible stent demonstrates favorable clinical effectiveness despite gradual expansion: a multicenter prospective study" j.Clin.Med.2023, 12, 850.Https://doi.Org/10.3390/jcm12030850.Block h6: imdrf patient code (b)(6) captures the reportable patient complication of sepsis.Imdrf patient code (b)(6) captures the reportable patient complication of severe cholangitis.Imdrf patient code (b)(6) captures the reportable patient complication of disseminated intravascular coagulation.Imdrf patient code (b)(6) captures the reportable patient complication of peritonitis.Imdrf patient code (b)(6) captures the reportable patient complication of bleeding (low hemoglobin level).Imdrf patient code (b)(6) captures the reportable patient complication of perforation.Imdrf impact code (b)(6) captures the reportable event of patient's death.Imdrf impact code of (b)(6) captures the unexpected medical intervention performed to address patient complication.Imdrf impact code f2303 captures the additional intervention of blood transfusion.

Event Description

Boston scientific corporation became aware of the following event through the article "gastroduodenal stenting with a flexible stent demonstrates favorable clinical effectiveness despite gradual expansion: a multicenter prospective study", by (b)(6), et al.According to the article, palliative stenting was prospectively carried out for gastric outlet obstruction (goo) at (b)(6) hospital) between october 2017 and august 2020.All procedures were performed using the wallflex duodenal soft stent with a diameter of 22 mm.A total of 60 patients (30 males and 30 females) were enrolled during the study period.The median age was 74 years (range: 40 - 92 years).Primary diseases included pancreatic cancer (n = 35, 53%), gastric cancer (n = 16, 27%), biliary tract cancer (n = 7, 12%), and other diseases (n = 5, 8%).The stenosis sites were pylorus.The gastric outlet obstruction scoring system (gooss) scores before duodenal stenting were 0 in fifty cases (83%), 1 in eight cases (13%), and 2 in two cases (3%).The procedure was performed under conscious sedation.A straight-view or side-view endoscope with a forceps channel of greater than or equal to 3.2 mm was advanced up to the stenosis.An endoscopic retrograde cholangiopancreatography catheter and a 0.025 - 0.035-inch biliary guidewire were used to cross the stenosis and perform contrast-enhanced imaging of the area.After confirming the stenosis length, the appropriate stent was selected.Subsequently, the stent delivery system, was advanced through the endoscope along the guidewire and deployed from the anal side.The procedure was completed by confirming proper placement under fluoroscopic or endoscopic guidance.According to the article, adverse events other than recurrent gastric outlet obstruction (rgoo) occurred after stenting in seven patients (12%); three out of seven patients expired.One patient developed sepsis and disseminated intravascular coagulation due to severe cholangitis the day after duodenal stenting.Although percutaneous biliary drainage was performed, the patient expired due to uncontrolled sepsis and dic.Perforation occurred in two patients.In one of the patients, perforation occurred 104 days after duodenal stenting.Surgery was not indicated in this patient due to the presence of end-stage gastric cancer.The patient expired due to perforative peritonitis.The other patient died 10 days later due to deterioration of the general condition, despite a blood transfusion for low hemoglobin levels following duodenal stenting.A pathological autopsy revealed perforation on the oral side of the duodenal stent.At the end of this study (b)(6) 2021, all patients, except one, had expired.There were 55 deaths (92%) due to primary diseases.Other causes of death included perforative peritonitis, perforation and hemorrhage, and severe cholangitis (one case each), as well as sudden death of unknown cause (one case).

• Brand Name: WALLFLEX COLONIC SOFT STENT SYSTEM WITH ANCHOR LOCK DELIVERY SYSTEM
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 17886261
• MDR Text Key: 325090645
• Report Number: 3005099803-2023-05183
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 10/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2023
• 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: 09/11/2023
• 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
• Patient Age: 74 YR