MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGILE ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number M00517630

Device Problems Use of Device Problem (1670); Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on february 01, 2022 that an agile esophageal fully covered rmv stent was implanted in the duodenum to treat benign pancreatitis during a procedure performed on (b)(6) 2021.Two weeks post stent placement, the stent had migrated into the stomach.Reportedly, the stent remains implanted.No patient complications were reported as a result of this event.The patient was reported to be fully recovered.Note: it was reported that the agile esophageal fully covered stent was implanted in the duodenum for benign pancreatitis.Per the ifu, "the agile esophageal fully covered rmv stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, occlusion of concurrent esophageal fistulas and treating refractory benign esophageal strictures." the stent is not indicated to be implanted in the duodenum.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Approximated 2 weeks after the implant date.(b)(4).The complainant indicated that stent remains implanted and 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.

Manufacturer Narrative

Approximated 2 weeks after the implant date.(b)(4).The complainant indicated that stent remains implanted and 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 february 01, 2022 that an agile esophageal fully covered rmv stent was implanted in the duodenum to treat benign pancreatitis during a procedure performed on (b)(6) 2021.Two weeks post stent placement, the stent had migrated into the stomach.Reportedly, the stent remains implanted.No patient complications were reported as a result of this event.The patient was reported to be fully recovered.Note: it was reported that the agile esophageal fully covered stent was implanted in the duodenum for benign pancreatitis.Per the ifu, "the agile esophageal fully covered rmv stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, occlusion of concurrent esophageal fistulas and treating refractory benign esophageal strictures." the stent is not indicated to be implanted in the duodenum.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• Brand Name: AGILE ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• 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: 13590730
• MDR Text Key: 286069495
• Report Number: 3005099803-2022-00938
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2023
• Device Model Number: M00517630
• Device Catalogue Number: 1763
• Device Lot Number: 0027718698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1