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

Model Number	M00516740
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/06/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal fully covered stent was to be used to treat a post surgical anastomotic leak in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed across the anastomotic section.However, the distal flange of the stent was not fully expanded and it appeared that the distal tip of the delivery system was hooked onto the distal end of the stent.During delivery system removal, the stent was pulled proximally out of position.The physician decided to remove the stent with rat tooth forceps and a different stent was placed to complete the procedure.There were no patient complications reported as a result of this event.Note: according to the complainant, the stent was to be used to treat a post surgical anastomotic leak in the esophagus.Per the dfu, "the wallflex 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".

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8375451
• Report Number: 3005099803-2019-00958
• Device Sequence Number: 16695203
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/27/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2020
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 0023109177
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2019
• Initial Report FDA Received Date: 02/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention