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

Device Problems Use of Device Problem (1670); Human-Device Interface Problem (2949)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/22/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation on march 23, 2022 that an agile esophageal tts was implanted to treat a benign stricture in the esophagus during a stent placement procedure performed on an unknown date.The stent was scheduled to be removed on (b)(6) 2022.During the scheduled stent removal procedure, upon removing the stent with forceps, esophageal tissue was noted on the outside of the stent.The patient encountered bleeding and was treated with clips.The patient was then sent to intensive care unit (icu) for monitoring.The patient was reported to be admitted to hospital beyond the standard of care.The patient is expected to fully recover.

Manufacturer Narrative

(b)(4).The complainant was unable to provide the suspect device upn or lot number; therefore, the lot expiration and device manufacture dates are unknown.The complainant indicated that the device was disposed 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

Block h6: medical device problem code a22 captures the reportable event of stent overgrowth.Patient code e0506 captures the reportable event of hemorrhage.Impact code f08 captures the patient's admission to the intensive care unit.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block d4, h4: the complainant was unable to provide the suspect device upn or lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: the complainant indicated that the device was disposed 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.Block h11: blocks b5 and h6 (device codes) have been corrected.

Event Description

It was reported to boston scientific corporation on march 23, 2022 that an agile esophageal tts was implanted to treat a benign stricture in the esophagus during a stent placement procedure performed on an unknown date.The stent was scheduled to be removed on (b)(6), 2022.During the scheduled stent removal procedure, upon removing the stent with forceps, esophageal tissue was noted on the outside of the stent.The patient encountered bleeding and was treated with clips.The patient was then sent to intensive care unit (icu) for monitoring.The patient was reported to be admitted to hospital beyond the standard of care.The patient is expected to fully recover.Update based on review on april 22, 2022 note: the agile esophageal tts was implanted to treat a benign stricture in the esophagus.However, the ifu states that, "the agile esophageal fully covered stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas." the stent is not intended to be placed to treat a benign stricture.

Event Description

It was reported to boston scientific corporation on march 23, 2022 that an agile esophageal tts was implanted to treat a benign stricture in the esophagus during a stent placement procedure performed on an unknown date.The stent was scheduled to be removed on (b)(6), 2022.During the scheduled stent removal procedure, upon removing the stent with forceps, esophageal tissue was noted on the outside of the stent.The patient encountered bleeding and was treated with clips.The patient was then sent to intensive care unit (icu) for monitoring.The patient was reported to be admitted to hospital beyond the standard of care.The patient is expected to fully recover.Update based on review on april 22, 2022.Note: the agile esophageal tts was implanted to treat a benign stricture in the esophagus.However, the ifu states that, "the agile esophageal fully covered stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas." and "stent is considered to be a permanent device.Once stent placement is permanently achieved, stent removal or repositioning is not recommended." the stent is not intended to be placed to treat a benign stricture, nor intended to be removed.

Manufacturer Narrative

Block h6: medical device problem code a22 captures the reportable event of stent overgrowth.Patient code e0506 captures the reportable event of hemorrhage.Impact code f08 captures the patient's admission to the intensive care unit.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block d4, h4: the complainant was unable to provide the suspect device upn or lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: the complainant indicated that the device was disposed 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.Block h11: block h6 (impact codes) has been corrected.

• 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: 14103721
• MDR Text Key: 289198923
• Report Number: 3005099803-2022-01919
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K180144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/01/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/22/2022; 05/10/2022
• Supplement Dates FDA Received: 05/16/2022; 06/01/2022
• 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): Hospitalization; Required Intervention