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

Model Number M00553540

Device Problems Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2021 that a hot axios stent was to be implanted transduodenal to the common bile duct to treat adenocarcinoma in the head of the pancreas during a choledochoduodenostomy procedure performed on (b)(6) 2021.During the procedure, the stent was unable to deploy and the inner sheath protruded out of the top of the handle.The stent was removed from the patient fully covered by the outer sheath.The procedure was completed by placing a fully covered metallic stent through the puncture site.The patient experienced moderate pain and was treated with paracetamol.Additionally, the patient was admitted to the hospital for 24 hours for follow up.The patient's condition was reported to be fully recovered.

Manufacturer Narrative

Block h6: medical device problem code a150201 captures the reportable event of stent failed to deploy in the common bile duct.Medical device problem code a0401 captures the reportable event of handle break.Impact code f08 captures the reportable event of hospitalization.Block h10: the device was returned for analysis with the stent fully covered and undeployed.The sheath was kinked at the distal section.The stainless steel, copper cable and inner sheath were protruding at the proximal section of the handle and the handle was broken.No other issues were noted with the returned device.Photos were provided by the complainant and reviewed for analysis, the first picture showed that the stainless steel, the copper cable and inner sheath are protruded in the handle at proximal section.The second picture showed the label of the device.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.With all available information, it is most likely that procedural factors encountered during procedure could have affected the device performance and its integrity.Handling and manipulation of the device during the procedure could lead to the sheath kink and this could cause the difficulty deploying the stent.Also, it is possible that excessive force during the attempted deployment could break the handle and lead to the stainless steel, the copper cable and inner sheath protrusion and inability to deploy the stent.Therefore the most probable cause of the event has been determined to be adverse event related to procedure.

Event Description

It was reported to boston scientific corporation on october 06, 2021 that a hot axios stent was to be implanted transbulboduodenal to the common bile duct during a choledochoduodenoanastomosis procedure performed on (b)(6) 2021.During the procedure, the stent was unable to deploy and the handle broke.The procedure was completed using a fully covered metallic stent.The patient experienced moderate pain and was treated with paracetamol.Additionally, the patient was admitted to the hospital for 24 hours for follow up.The patient's condition was reported to be fully recovered.

• Brand Name: AXIOS STENT AND 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: 12699034
• MDR Text Key: 278408563
• Report Number: 3005099803-2021-05571
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K150692
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: M00553540
• Device Catalogue Number: 5354
• Device Lot Number: 0026298458
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Female
• Patient Weight: 58 KG