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

Model Number M00553660

Device Problems Electrical /Electronic Property Problem (1198); Use of Device Problem (1670); Positioning Problem (3009); Activation Failure (3270)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/04/2022

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on april 06, 2022 that an axios stent and electrocautery enhanced delivery system was to be implanted transgastric to the jejunum during a gastrojejunostomy procedure performed on (b)(6) 2022.The implantation site was examined with eus doppler prior to deploying the stent.During the procedure, there was difficulty creating a puncture using the axios electrocautery enhanced delivery system.The stent first flange was deployed; however, the first flange did not fully expand and moved out of its position.The stent was removed partially deployed and another axios stent was implanted to complete the procedure.Reportedly, there was bleeding noted at the puncture site which resolved without any treatment.In the physician's assessment, there was a relationship between the bleeding and the axios stent.The patient experienced bleeding at the puncture site and in the physician's assessment, there was a relationship between the bleeding and the axios stent.The patient's condition at the conclusion of the procedure was reported to be fully recovered.It was reported that the axios stent was intended to be placed for a gastrojejunostomy procedure.However, per the hot axios stent and electrocautery- enhanced delivery system directions for use, the stent is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6 cm in size and walled-off necrosis >= 6 cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.The device is not indicated to be placed in the transgastric to jejunum.

• 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: 14251996
• MDR Text Key: 290448953
• Report Number: 3005099803-2022-02244
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2023
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0028658915
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2022
• 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