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

Model Number M00553650

Device Problems Use of Device Problem (1670); Device-Device Incompatibility (2919); Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).The complainant was unable to report the upn or lot number; therefore, the manufacture date, expiration date, and udi# are unknown.(b)(6) clinical trial.(b)(4).The complainant indicated that the device has been disposed of 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a hot axios stent was successfully implanted in a transgastric position to treat a pancreatic walled-off necrosis during an inpatient procedure performed on (b)(6) 2019.There were no issues noted with the device and no patient complications during the procedure.Reportedly, a computed tomography (ct) scan was performed on (b)(6) 2018, and the cyst was confirmed to be 280mm in size.A total of six necrosectomy procedures were performed following stent placement.Reportedly, the patient's cyst contained 90% necrotic material.The stent was placed as part of the (b)(6) clinical trial.According to the complainant, post stent placement, necrosectomy was performed 6 times.On (b)(6) 2019, during the fifth necrosectomy procedure, the stent unintentionally dislodged from the implant location.The stent was removed from the patient.According to the complainant, another stent was not needed and the procedure was completed without implanting a new device.There were no patient complications reported as a result of this event.Note: the stent was intended to be placed to treat a cyst with less than 70% liquid content; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.

Manufacturer Narrative

Blocks b5, d4 (model number, lot number, catalog number, expiration date, and udi #), e1 (initial reporter name), h4, and h6 (device codes) have been updated.Block a1: the patient's initials are (b)(6).Block g3: (b)(4).Block h6: device code 4003 captures the reportable event of stent migrated.Block h10: the complainant indicated that the device has been disposed of 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a hot axios stent was successfully implanted in a transgastric position to treat a pancreatic walled-off necrosis during an inpatient procedure performed on (b)(6) 2019.There were no issues noted with the device and no patient complications during the procedure.Reportedly, a computed tomography (ct) scan was performed on (b)(6) 2018, and the cyst was confirmed to be 280mm in size.A total of six necrosectomy procedures were performed following stent placement.Reportedly, the patient's cyst contained 90% necrotic material.The stent was placed as part of the e7121 axios japan pms clinical trial.According to the complainant, post stent placement, necrosectomy was performed 6 times.On (b)(6) 2019, during the fifth necrosectomy procedure, the stent unintentionally dislodged from the implant location.The stent was removed from the patient.According to the complainant, another stent was not needed and the procedure was completed without implanting a new device.There were no patient complications reported as a result of this event.Note: the stent was intended to be placed to treat a cyst with less than 70% liquid content; however, the hot axios stent and delivery system is indicated for use to facilitate transgastric or transduodenal endoscopic drainage of symptomatic pancreatic pseudocysts >= 6cm in size and walled-off necrosis >= 6cm in size with >= 70% fluid content that are adherent to the gastric or bowel wall.***additional information received on 09sep2019*** the axios stent dislodged during the necrosectomy procedure performed on (b)(6) 2019 because it got caught on the necrosectomy device.

• 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
• MDR Report Key: 8967722
• MDR Text Key: 160020888
• Report Number: 3005099803-2019-04405
• Device Sequence Number: 1
• Product Code: PCU
• 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: 10/03/2019

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2020
• Device Model Number: M00553650
• Device Catalogue Number: 5365
• Device Lot Number: 0023040395
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/09/2019
• Supplement Dates FDA Received: 10/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR
• Patient Weight: 79