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

Model Number	M00516750
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	08/06/2019
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 medwatch 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 in the esophagus to treat post gastric sleeve during a stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not dilated.According to the complainant, during the procedure, the stent would not deploy on the first attempt.On the second attempt, the device was withdrawn up closer and the stent was able to be deployed, however; the stent was placed a little higher from the target stricture.Reportedly, the physician was not happy on the location of the stent.The stent was removed from the patient and no other stent was implanted.There were no patient complications reported as a result of this event.According to the complainant, the wallflex esophageal fully covered stent was used to treat post gastric sleeve.Per the wallflex esophageal stent directions for use (dfu), the wallflex esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and / or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Additional Manufacturer Narrative
Blocks b5, d6 , d7, and h6 (patient code) have been updated with the additional information received on september 06, 2019.Block h6: patient code 3191 captures the additional intervention to remove the stent during a second procedure.Problem code 3009 captures the reportable event of stent positioning problem.Conclusion code 4316 is being used in lieu of an adequate conclusion for device not returned.Block h0: 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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on august 6, 2019 that a wallflex esophageal fully covered stent was to be used in the esophagus to treat post gastric sleeve during a stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not dilated.According to the complainant, during the procedure, the stent would not deploy on the first attempt.On the second attempt, the device was withdrawn up closer and the stent was able to be deployed, however; the stent was placed a little higher from the target stricture.Reportedly, the physician was not happy on the location of the stent.The stent was removed from the patient and no other stent was implanted.There were no patient complications reported as a result of this event.Note: according to the complainant, the wallflex esophageal fully covered stent was used to treat post gastric sleeve.Per the wallflex esophageal stent directions for use (dfu), the wallflex esophageal stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.Additional information received on september 06, 2019.According to the complainant, the stent was removed on (b)(6) 2019, during a second procedure performed later that day.

• 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: 8945983
• Report Number: 3005099803-2019-04238
• Device Sequence Number: 2585043
• Product Code: ESW
• UDI-Device Identifier: 08714729778080
• UDI-Public: 08714729778080
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 09/23/2020
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0023541071
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/06/2019
• Supplement Date Received by Manufacturer: 09/06/2019
• Initial Report FDA Received Date: 08/29/2019
• Supplement Report FDA Received Date: 10/01/2019
• 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