MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM; PANCREATIC STENT, COVERED, METALLIC, REMOVABLE

Device Problems Use of Device Problem (1670); Positioning Problem (3009); Migration (4003)

Patient Problems Abscess (1690); Erosion (1750); Hemorrhage/Bleeding (1888); Perforation (2001); Insufficient Information (4580)

Event Date 01/19/2023

Event Type  Injury  

Event Description

Boston scientific corporation became aware of the following event through the article "real-life indications and outcome of electrocautery-enhanced lumen-apposing metal stents in a tertiary center" by dr.Antonia gantschnigg, et.Al.The study aims to evaluate the indication, safety, efficacy, and outcome of all lumen-apposing metal stent (lams) implanted in a single tertiary referral center.According to the literature, a retrospective, single-center analysis of all patients who had undergone endoscopic ultrasound-guided drainage with an electrocautery-enhanced lumen-apposing metal stents, including all indications, between april 20i6 until april 2022 was performed.A total of 86 stents were placed in 77 patients (45 female: 41 male) ranging from 20-96-year-old; indications were walled-off pancreatic necrosis (25.6%), bile duct obstructions (16.3%), acute cholecystitis (15.1 %), pancreas pseudocysts (15.1 %), postoperative collections (10.5%), postoperative pancreatic fistulas (9.3%), and gastro-gastrostomy/ jejunostomy (8.1%).Based on the literature, a total of 10 (11.7%) adverse events were observed.Two intraprocedural complications during hot axios placement were noted, one perforation and one secondary dislocation.A total of 7 episodes of bleeding were observed in four patients.Perforation was observed during the attempt to perform a gastrojejunostomy in a patient with cholangitis due to stenosis of the hepaticojejunostomy, requiring surgical revision with the removal of the misplaced stent after laparotomy and surgical closure of the defect.Secondary dislocation was observed while performing a choledochoduodenostomy after puncturing and instillation of contrast fluid and insertion of a guidewire in the main bile duct to enable bile drainage in a patient with distal malignant bile duct stenosis.This complication was managed by passing a guidewire through the distal bile duct stenosis from an antegrade direction (the puncture site) and grasping it in a rendezvous technique.Afterward, transpapillary implantation of a covered metal stent was possible.Through this route, access to the hot axios implantation site was achieved, and we succeeded in removing the hot axios stent.Closure of the lumen-apposing metal stent implantation site was performed with 2 clips on the duodenal site and healed without further complications.The patient had no side effects, the transpapillary stent was changed on a regular basis with full resolution of cholestasis.Bleeding episodes occurred 7 times (8.2%) in a total of 4 patients after stent implantation.In all cases, a gastroscopy was performed.Local bleeding from mucosa! erosions caused by the erosion from the stent was observed three times.In 1 patient, no treatment was needed, 2 patients required 2 and 3 gastroscopies, respectively, with clip placement to stop the bleeding.In 1 patient, bleeding was observed from the necrotic cavity after stent implantation due to walled-off-necrosis (won).Clips were placed to stop the bleeding.Two postprocedural adverse events occurred after the implantation of a hot axios device.In one patient, a stent was placed transgastrically to drain a peri-pancreatic retention due to a postoperative pancreatic fistula.One day after the intervention, there was a rapid clinical deterioration, and the patient presented with an acute abdomen requiring laparotomy.Minor arterial bleeding was found next to the stent site, originating from a small arterial vessel of the pancreatic parenchyma.The bleeding was stopped with a monopolar electrocautery, the stent was removed, and the hole in the stomach was sewn up.The patient was asymptomatic afterward.However, the same patient developed a recurrent peri-pancreatic retention and another hot axios stent was placed 3 months later without any complication.In another patient, a lumen-apposing metal stent was placed to perform a gastro-gastrostomy to gain access for performing an endoscopic retrograde cholangiopancreatography (ercp) after gastric bypass.Six days after the uncomplicated implantation, the stent dislocated while attempting to move the duodenoscope through the stent into the duodenum, leaving both lumina, the gastric pouch, and the gastric remnant open to the abdominal cavity.An immediate laparotomy with extraction of the stent and suturing of the perforation was performed.Choledocholithiasis was removed by performing a choledochotomy and t-tube drainage during surgery.Bleeding control was sufficient in all cases.Note: according to the literature, the axios stent was used to treat postoperative pancreatic fistulas and gastro-gastrostomy/ jejunostomy.However, per the axios stent and electrocautery-enhanced delivery system instructions for use (ifu), the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of a pancreatic pseudocyst or a walled-off necrosis with >= 70% fluid content, gallbladder in patients with acute cholecystitis who are at high risk or unsuitable for surgery, and the bile duct after failed endoscopic retrograde cholangiopancreatography (ercp) in patients with biliary obstruction due to a malignant stricture.The device is not indicated for postoperative pancreatic fistulas and gastro-gastrostomy/ jejunostomy.

Manufacturer Narrative

Block b3: the exact date of event was not reported.The article published date is used for the estimated date of event.Block d4, h4: the literature article did not provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.Block g2: literature source: gantschnigg, antonia md; singhartinger, franz md; von rahden, burkhard md; muhlbacher, iris md; koch, oliver owen md; emmanuel, klaus md; holzinger, josef md."real-life indications and outcome of electrocautery-enhanced lumen-apposing metal stents in a tertiary center".Surgical laparoscopy, endoscopy & percutaneous techniques 33(5): p 527-532, october 2023.| doi: 10.1097/sle.0000000000001201 block h6: imdrf patient code e2114 captures the reportable patient complication of perforation.Imdrf patient code e0506 captures the reportable patient complication of bleeding.Imdr patient code e2006 captures the reportable patient complication of tissue erosion.Imdrf patient code e172001 captures the reportable event of patient developed a recurrent peri-pancreatic retention.Imdrf patient code e2401 captures the reportable event of patient presented with an acute abdomen requiring laparotomy.Imdrf device code a010402 captures the reportable event of stent migration.Imdrf device code a1502 captures the reportable event of stent positioning issue, imdrf impact code f2202 captures the additional endoscopic procedure.Imdrf impact code f19 captures the surgical procedure.Imdrf impact code f23 and f2301 capture the additional intervention and the used of clips and electrocautery to treat the bleeding.

• Brand Name: AXIOS STENT AND ELECTROCAUTERY ENHANCED DELIVERY SYSTEM
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• 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: 18972329
• MDR Text Key: 338557048
• Report Number: 3005099803-2024-01191
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• 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: 02/28/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention