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

Model Number M00517810

Device Problem Migration (4003)

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

Event Date 05/12/2022

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that an agile esophageal otw stent was implanted on an unknown date.On (b)(6) 2022, post stent placement, it was noted that the agile esophageal stent had completely migrated distally.There are no known patient complications due to this event.Note: no further information has been obtained despite good faith efforts.

Manufacturer Narrative

(b)(4).The agile esophageal stent has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Manufacturer Narrative

A1, e1 (initial reporter facility name, address, city, initial reporter country, and post code), e3 (occupation and g2 (report source (other) have been updated with additional information received on july 28, 2022.Medical device problem code a010402 captures the reportable event of stent migration.The agile esophageal stent has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on july 18, 2022 that an agile esophageal otw stent was implanted on an unknown date.On may 12, 2022, post stent placement, it was noted that the agile esophageal stent had completely migrated distally.There are no known patient complications due to this event.

Manufacturer Narrative

Block h6: medical device problem code a010402 captures the reportable event of stent migration.Block h10: the agile esophageal stent has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.Block h11: block b5 has been corrected.

Event Description

It was reported to boston scientific corporation on (b)(6) 2022 that an agile esophageal otw stent was implanted on an unknown date as part of the e7118 agile esophageal stent clinical study.On (b)(6) 2022, post stent placement, it was noted that the agile esophageal stent had completely migrated distally.There are no known patient complications due to this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.Additional information received on september 12, 2022: the event is not a part of an e7118 agile esophageal stent clinical study.Rather, the event came from e7118 endoscopy post market surveillance; a post market surveillance data collection on commercially available boston scientific devices that are used per the approved indications for use.

• Brand Name: AGILE ESOPHAGEAL OTW
• 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: 15153606
• MDR Text Key: 302006046
• Report Number: 3005099803-2022-04263
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K211960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/04/2022

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: 03/01/2024
• Device Model Number: M00517810
• Device Catalogue Number: 1781
• Device Lot Number: 0028968101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/18/2022
• Initial Date FDA Received: 08/02/2022
• Supplement Dates Manufacturer Received: 07/28/2022; 09/12/2022
• Supplement Dates FDA Received: 08/25/2022; 10/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1