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

Model Number M00553650

Device Problems Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Laceration(s) (1946); Perforation (2001)

Event Date 10/27/2021

Event Type  Injury  

Manufacturer Narrative

The event was reported by the distributor.The reported physician and healthcare facility is: (b)(6).(b)(4).The complainant indicated that the device 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.

Event Description

It was reported to boston scientific corporation on october 28, 2021 that a hot axios stent was implanted to treat a 10-12cm pancreatic pseudocyst during a procedure performed on (b)(6) 2021.On (b)(6) 2021, the stent was removed using a snare during a routine removal per protocol; however, during removal, a laceration was created on the opposite side of the cyst.A cyst wall suture surgery was performed to treat the laceration.The patient was admitted to the intensive care unit (icu).

Event Description

It was reported to boston scientific corporation on october 28, 2021 that a hot axios stent was implanted to treat a 10-12cm pancreatic pseudocyst during a procedure performed on (b)(6) 2021.On (b)(6) 2021, the stent was removed using a snare during a routine removal per protocol; however, during removal, a perforation was created on the opposite side of the cyst.A cyst wall suture surgery was performed to treat the perforation.The patient was admitted to the intensive care unit (icu).Additional information received on november 24, 2021 during the routine stent removal procedure, it was noted that the opposite side of the cyst was adhered to the intestinal tract.When the axios stent was attempted to be removed, there was difficulty removing the stent and a perforation occurred where the cyst was adhered to the intestinal tract.

Manufacturer Narrative

Blocks b5 and h6 (device codes) have been updated with additional information received on november 24, 2021.Block e1: the event was reported by the distributor.The reported physician and healthcare facility is: (b)(4).Block h6: medical device problem code a150207 captures the reportable event of stent difficult to remove.Patient code (b)(6) captures the reportable patient issue of perforation.Impact code f19 captures the reportable event of surgery performed.Impact code f0801 captures the reportable event of the patient being admitted to the intensive care unit.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 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 b5 and h6 (patient codes) have been corrected.

• Brand Name: AXIOS
• 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: 12845150
• MDR Text Key: 281027270
• Report Number: 3005099803-2021-05958
• Device Sequence Number: 1
• Product Code: PCU
• UDI-Device Identifier: 08714729904595
• UDI-Public: 08714729904595
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/14/2021

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 Model Number: M00553650
• Device Catalogue Number: 5365
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2021
• Initial Date FDA Received: 11/19/2021
• Supplement Dates Manufacturer Received: 11/19/2021
• Supplement Dates FDA Received: 12/14/2021
• 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