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

Model Number M00553640

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

Patient Problems Hemorrhage/Bleeding (1888); Vomiting (2144); Embolism/Embolus (4438); Hematemesis (4478)

Event Date 01/26/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that a hot axios stent was implanted transgastric to the pancreas to treat a pancreatic pseudocyst during a cystgastrostomy procedure performed on (b)(6) 2022.On (b)(6) 2022, during emergent follow- up, the patient presented with hematemesis.The patient had upper gastrointestinal bleeding and was sent to interventional radiology (ir).Angiography was performed and no active bleeding was noted; however, the left gastric artery and splenic artery were embolized.On (b)(6) 2022, bleeding was noted again.Endoscopic ultrasound (eus) guided coils and glue of the splenic varices were performed.The stent remains implanted and the physician is comfortable leaving the stent in place.The patient is being evaluated and will be going into surgery.In the physician's assessment the axios stent is related to the patient complications as the splenic varix error into axios stent.

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device remains implanted 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.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: patient code e1016 captures the reportable event of hematemesis.Patient code e0506 captures the reportable event of bleeding.Impact code f23 captures the reportable event of eus guided coils placement.Impact code f08 captures the reportable event of prolonged hospitalization.Impact code f19 captures the reportable event of planned surgery.Evaluation conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device remains implanted 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.Block h11: blocks h6 (patient codes) and h10 have been corrected.

Event Description

It was reported to boston scientific corporation on february 01, 2022 that a hot axios stent was implanted transgastric to the pancreas to treat a pancreatic pseudocyst during a cystgastrostomy procedure performed on (b)(6) 2022.On (b)(6) 2022, during emergent follow- up, the patient presented with hematemesis.The patient had upper gastrointestinal bleeding and was sent to interventional radiology (ir).Angiography was performed and no active bleeding was noted; however, the left gastric artery and splenic artery were embolized.On (b)(6) 2022, bleeding was noted again.Endoscopic ultrasound (eus) guided coils and glue of the splenic varices were performed.The stent remains implanted and the physician is comfortable leaving the stent in place.The patient is being evaluated and will be going into surgery.In the physician's assessment the axios stent is related to the patient complications as the splenic varix errored into axios stent.

• 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: 13591269
• MDR Text Key: 286057412
• Report Number: 3005099803-2022-00902
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: 08714729904588
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153088
• 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,Followup
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M00553640
• Device Catalogue Number: 5364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/01/2022
• Initial Date FDA Received: 02/24/2022
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/23/2022
• 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; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 76 KG
• Patient Race: White