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

Device Problems Activation Failure (3270); Migration (4003); Device Stenosis (4066)

Patient Problems Inflammation (1932); Pancreatitis (4481)

Event Date 10/01/2017

Event Type  Injury  

Manufacturer Narrative

Block a2: age patient age is approximated based on the median age.Block b3: date of event: approximated to october 01, 2017, to august 31, 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 october 01, 2017, first date of the month of palliative stenting.Block g2: report source literature source: shigoka, h., 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 e1109 captures the reportable patient adverse event of cholangitis imdrf patient code e2326 captures the reportable patient adverse event of acuta cholecystitis.Imdrf patient code e1021 captures the reportable patient adverse event of pancreatitis.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a150101 captures the reportable event of stent expansion failure.Imdrf device code a0106 captures the reportable event of stent obstruction.Imdr impact code f23 is being used to address the additional procedure performed to address patient adverse event.Imdrf impact code f2301 is being used to address the use of additional stent and dilatation balloon to resolve patient adverse event.

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 hiroaki shigoka, et al.According to the article, palliative stenting was prospectively carried out for gastric outlet obstruction (goo) at seven university hospitals (toho university ohashi medical center, kyorin university hospital, juntendo university hospital, the university of tokyo hospital, showa university hospital, keio university hospital, and st.Marianna university 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 was 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.There were 54 cases with improvement in the gastric outlet obstruction (goo) at 7 days after stenting, with a clinical success rate of 90%.There was no improvement in six cases.Recurrent gastric outlet obstruction (rgoo) developed in 15 patients (25%).Tumor ingrowth occurred in seven patients (12%), six of whom underwent additional duodenal stenting.One patient did not request treatment and received conservative therapy.Four patients (7%) developed obstruction due to abutment of the stent edge caused by shortening of the duodenal stent.All patients were able to resume food intake as a result of improvement following the additional duodenal stenting.Insufficient expansion was observed in three patients (5%), and all patients underwent balloon dilation and additional duodenal stenting.Migration was observed in two patients (3%).One case involved insufficient expansion of the stent.Hence, a second stent was placed to overcome unsatisfactory expansion.However, the additional stent migrated into the stomach the following day.Although the migrated stent was removed endoscopically, insufficient expansion remained.Balloon dilation and additional duodenal stenting were performed after 11 days.According to the article adverse events other than recurrent gastric outlet obstruction (rgoo) occurred after stenting.Cholangitis occurred in three patients, in whom the stent crossed the duodenal papilla; two of those patients improved after conservative treatment without drainage.Acute cholecystitis occurred in one patient, who experienced improvement following percutaneous transhepatic gallbladder drainage.Mild acute pancreatitis occurred in one patient and resolved after conservative treatment.

• 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: 17886369
• MDR Text Key: 325093427
• Report Number: 3005099803-2023-05221
• 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): Required Intervention
• Patient Age: 74 YR