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

Model Number M00553640

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

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348); No Code Available (3191)

Event Date 01/17/2020

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(6).(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure 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 that a hot axios stent was implanted in a transgastric position to treat a pancreatic pseudocyst during a hot axios placement procedure on (b)(6) 2019.The axios stent was implanted successfully without issues and the procedure was completed by placing an additional double pigtail stent and drainage was successful.Reportedly, on (b)(6) 2020, it was noted that the patient had moderate black stool.The patient was hospitalized and a transfusion was performed.On (b)(6) 2020, no issues were noted with the hot axis stent, placement was still correct and the stent was in an open state.The hot axios stent was removed from the patient without issue on this date.On (b)(6) 2020 it was noted that the patient's condition improved.On (b)(6) 2020 a follow-up was conducted 7 days after removal and there were no adverse events to the patient.In the physician's opinion the adverse event has a causal relationship with this device.There were no alleged deficiencies or issues reported with the hot axios itself.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that a hot axios stent was implanted in a transgastric position to treat a pancreatic pseudocyst during a hot axios placement procedure on (b)(6), 2019.The axios stent was implanted successfully without issues and the procedure was completed by placing an additional double pigtail stent and drainage was successful.Reportedly, on (b)(6), 2020, it was noted that the patient had moderate black stool.The patient was hospitalized and a transfusion was performed.On (b)(6), 2020, no issues were noted with the hot axis stent, placement was still correct and the stent was in an open state.The hot axios stent was removed from the patient without issue on this date.On (b)(6), 2020 it was noted that the patient's condition improved.On (b)(6) 2020 a follow-up was conducted 7 days after removal and there were no adverse events to the patient.In the physician's opinion the adverse event has a causal relationship with this device.There were no alleged deficiencies or issues reported with the hot axios itself.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.***additional information received on (b)(6)2020*** the reported hospitalization and transfusion was performed as treatment for the black stool.The patient was reported to be recovering.It was reported that the patient had an underlying splenic aneurism that may have contributed to the black stool.

Manufacturer Narrative

Block b5 has been updated with additional information received.Block h11: block h6 patient code has been corrected.Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, it was reported that the device was not used past the expiration date.Block g3: e7121 axios japan post market survey block h6: patient code 1888 captures the reported black stool.Patient code 3191 captures hospitalization and transfusion performed.Block h10: the complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: AXIOS
• Type of Device: PANCREATIC STENT, COVERED, METALLIC, REMOVABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9874143
• MDR Text Key: 189609448
• Report Number: 3005099803-2020-01234
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904588
• UDI-Public: 08714729904588
• Combination Product (y/n): N
• PMA/PMN Number: K153088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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
• Initial Date Manufacturer Received: 03/02/2020
• Initial Date FDA Received: 03/24/2020
• Supplement Dates Manufacturer Received: 03/24/2020
• Supplement Dates FDA Received: 04/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR
• Patient Weight: 87