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

Model Number M00553560

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a hot axios stent was to be implanted in a transgastric position to treat a pancreatic necrotic cyst during a procedure performed on (b)(6) 2019.Reportedly, the patient's cyst contained no fluid and was composed of only solid material.An external drainage was present within the cyst.According to the complainant, during the procedure, after the deployment handle was retracted to step #2 in order to deploy the first flange of the stent, the first flange failed to expand.The device was removed from the patient with the stent partially deployed on the delivery system.The physician attempted to place a second hot axios stent, but the same issue occurred.The device was removed from the patient with the stent partially deployed on the delivery system.A third hot axios stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.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

Block h6: device code 3270 captures the reportable event of stent first flange failure to expand.Block h10: a hot axios stent and delivery system was returned for analysis.A visual inspection noted that the stent was received deployed and expanded.The stent deployment hub was at step #4, the catheter hub was in its original position, and the catheter lock was unlocked.A kink was noted in the polyimide inner.A functional evaluation noted the catheter control hub advanced and retracted without resistance.The stent deployment hub was also able to be moved without resistance.The stent was measured to be within specifications.No other issues with the device were noted.The kink in the polyimide inner may be a result of device manipulation post procedure outside the patient.A labeling review was performed and confirmed that the device was not used in a manner consistent with the labeling.The hot axios stent was being implanted to treat a cyst with no fluid and only solid material; according to the directions for use (dfu), 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.The reported expansion issue is most likely a result of the high necrotic material present in the cyst.Therefore, a review and analysis of all available information indicated that the most probable root cause is cause traced to intentional off-label, unapproved, or contraindicated use.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

Note: this report pertains to one of two devices used during the same procedure.It was reported to boston scientific corporation that a hot axios stent was to be implanted in a transgastric position to treat a pancreatic necrotic cyst during a procedure performed on (b)(6), 2019.Reportedly, the patient's cyst contained no fluid and was composed of only solid material.An external drainage was present within the cyst.According to the complainant, during the procedure, after the deployment handle was retracted to step #2 in order to deploy the first flange of the stent, the first flange failed to expand.The device was removed from the patient with the stent partially deployed on the delivery system.The physician attempted to place a second hot axios stent, but the same issue occurred.The device was removed from the patient with the stent partially deployed on the delivery system.A third hot axios stent was placed to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.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.

• 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: 9536318
• MDR Text Key: 189878948
• Report Number: 3005099803-2019-06321
• Device Sequence Number: 1
• Product Code: PCU
• Combination Product (y/n): N
• PMA/PMN Number: SIMILAR
• 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: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/14/2020
• Device Model Number: M00553560
• Device Catalogue Number: 5356
• Device Lot Number: 0024269813
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2020
• Initial Date Manufacturer Received: 12/05/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 02/05/2020
• Supplement Dates FDA Received: 02/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1