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

Model Number M00553660

Device Problems Break (1069); Premature Activation (1484); Use of Device Problem (1670); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).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

It was reported to boston scientific corporation on august 26, 2020 that a hot axios stent was to be implanted transgastric to the jejunum during a gastrojejunostomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while advancing the wire through the scope, the first flange prematurely deployed.Reportedly, the guidewire was stripped and stuck inside the axios device.The stent was removed and another hot axios stent was used 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 fine.A photo of the device provided by the complainant after the procedure shows that the inner sheath is sticking out of the handle and the stent is partially deployed.Note: according to the complainant, the axios stent was placed for a gastrojejunostomy.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 for placement in the jejunum.

Event Description

It was reported to boston scientific corporation on (b)(6) 2020 that a hot axios stent was to be implanted transgastric to the jejunum during a gastrojejunostomy procedure performed on (b)(6) 2020.According to the complainant, during the procedure, while advancing the wire through the scope, the first flange prematurely deployed.Reportedly, the guidewire was stripped and stuck inside the axios device.The stent was removed and another hot axios stent was used 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 fine.A photo of the device provided by the complainant after the procedure shows that the inner sheath is sticking out of the handle and the stent is partially deployed.Note: according to the complainant, the axios stent was placed for a gastrojejunostomy.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 for placement in the jejunum.

Manufacturer Narrative

Block h6: problem code 1484 captures the reportable event of stent first flange prematurely deployed in the jejunum.Problem code 1069 captures the reportable event of handle break.Block h10: a hot axios stent and delivery system were returned for analysis.The stent was received partially deployed and the delivery system was returned in initial position with the retainer clip attach.The guidewire was also received stuck in the catheter with one section outside the monopolar section.Visual examination of the returned device found the stent cover was damaged (holes).The outer sheath was kinked near the luer section.A destructive inspection was necessary to find evidence of torsion (rotational damage) and the sheath was found in good condition.No other issues with the stent and delivery system were noted.The reported event of stent premature deployment could not be confirmed; this failure occurred during the procedure and it is not possible to replicate in the laboratory of analysis.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the directions for use (dfu)/ product label.The complainant reported that the stent was implanted for a gastrojejunostomy.The dfu states, "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".However, the device was placed in the jejunum, which is not indicated in the dfu.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that the incorrect use of the device and placing in a different anatomical condition than indicated, would not have the intended result as this would effect functional capabilities of the axios stent, limited the performance of the device and contributed to stent premature deployment, stent cover damaged and outer sheath kinked.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• 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: 10541593
• MDR Text Key: 207176850
• Report Number: 3005099803-2020-03986
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729951179
• UDI-Public: 08714729951179
• Combination Product (y/n): N
• PMA/PMN Number: K163272
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: M00553660
• Device Catalogue Number: 5366
• Device Lot Number: 0025703181
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/16/2020
• Supplement Dates Manufacturer Received: 10/23/2020
• Supplement Dates FDA Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention