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

Model Number	M00516750
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Dysphagia/ Odynophagia (1815)
Date of Event	05/24/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device component coded 515 relates to problem code 1395 for the reported event of stent migration.The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018, that a wallflex esophageal fully covered stent was implanted to treat a 5-6 cm benign peptic stricture in the stomach near the esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was very tight.According to the complainant, on (b)(6) 2018, post stent placement, the patient presented with dysphagia.An x-ray was performed to check for stent placement, and noted the stent had migrated.On (b)(6) 2018, the stent was removed with forceps during an esophagogastroduodenoscopy procedure.Reportedly, the patient's anatomy was dilated prior to stent removal.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
A deployed and expanded wallflex esophageal fully covered stent was received for analysis; the delivery system was not returned.Visual examination of the returned device found a break in the stent retrieval suture.The stent was measured to be within specifications.No other issues with the stent were noted.The reported event that the stent migrated could not be confirmed based on the analysis of the returned device.The investigation concluded that the observed damage to the retrieval suture was likely a result of manipulation during withdrawal of the stent.The investigation concluded that migration is a known potential complication of metal stent placement and is noted within the directions for use (dfu).Therefore, the most probable root cause is anticipated procedural complications.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.A product labeling review identified that device was used in a manner inconsistent with the directions for use (dfu).Per the dfu, the device is contraindicated for "placement in esophageal strictures caused by benign tumors, as the long-term effects of the stent in the esophagus are unknown;" however, according to the complainant, the stent was implanted to treat a benign peptic stricture.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018, that a wallflex esophageal fully covered stent was implanted to treat a 5-6 cm benign peptic stricture in the stomach near the esophagus during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was very tight.According to the complainant, on (b)(6) 2018, post stent placement, the patient presented with dysphagia.An x-ray was performed to check for stent placement, and noted the stent had migrated.On (b)(6) 2018, the stent was removed with forceps during an esophagogastroduodenoscopy procedure.Reportedly, the patient's anatomy was dilated prior to stent removal.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• Brand Name: WALLFLEX¿ ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7602048
• Report Number: 3005099803-2018-01858
• Device Sequence Number: 16618968
• 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: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 09/26/2019
• Device Model Number: M00516750
• Device Catalogue Number: 1675
• Device Lot Number: 0021920756
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Initial Date Received by Manufacturer: 05/24/2018
• Supplement Date Received by Manufacturer: 07/07/2018
• Initial Report FDA Received Date: 06/14/2018
• Supplement Report FDA Received Date: 08/03/2018
• 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: 60 YR