MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number	M00516950
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted 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
Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report# 3005099803-2017-02591 and 3005099803-2017-02593 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2017 that two wallflex esophageal partially covered stents were implanted to treat a leak just above a malignant stricture.Reportedly, the patient¿s anatomy was tortuous and was surgically-altered.According to the complainant, on (b)(6) 2017, the first stent (the subject of mfr.Report# 3005099803-2017-02591) was successfully implanted but was scheduled to be replaced as it was not the physician¿s stent of choice.On (b)(6) 2017, during the scheduled stent exchange procedure, the physician could not remove the first implanted stent.The physician decided to leave the first stent implanted.The second stent (the subject of this report) was deployed within the first stent but was implanted hanging into the stomach.The second stent was repositioned using forceps to overlap the leakage area and bleeding in the stomach was noted.No intervention was done to treat the bleed and it resolved on its own.The physician left both stents implanted and completed the procedure.The physician is confident in leaving both stent in the patient and does not plan to remove either stent.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6816317
• Report Number: 3005099803-2017-02593
• Device Sequence Number: 16180354
• Product Code: ESW
• UDI-Device Identifier: 08714729765295
• UDI-Public: (01)08714729765295(17)20190704(10)20845457
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/04/2017

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: 07/04/2019
• Device Model Number: M00516950
• Device Catalogue Number: 1695
• Device Lot Number: 20845457
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2017
• Initial Report FDA Received Date: 08/24/2017
• 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
• Patient Age: 69 YR