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

Model Number	M00516700
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/24/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 that a wallflex esophageal fully covered stent was implanted to treat an approximately 7cm benign stricture in the mid esophagus during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure the stent did not fully expand.X-ray was performed after 24 and 48 hours post stent placement procedure and the stent still did not expand.Reportedly, on (b)(6) 2020, the stent was removed and another wallflex esophageal stent was implanted to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b5 and b7 have been updated with additional information received on (b)(6), 2020.Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 3270 captures the reportable event of stent failed to expand.Patient code 3191 captures the intervention to remove the stent during second procedure.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2020 that a wallflex esophageal fully covered stent was implanted to treat a benign stricture in the mid esophagus during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure the stent did not fully expand.X-ray was performed after 24 and 48 hours post stent placement procedure and the stent still did not expand.Reportedly, on (b)(6), 2020, the stent was removed and another wallflex esophageal stent was implanted to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.***additional information received on (b)(6), 2020*** reportedly, previously the stricture was measured to be around 3cm.

• 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: 9862736
• Report Number: 3005099803-2020-01048
• Device Sequence Number: 19563404
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: 08714729778035
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2020

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: 09/02/2020
• Device Model Number: M00516700
• Device Catalogue Number: 1670
• Device Lot Number: 0023438500
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/24/2020
• Supplement Date Received by Manufacturer: 09/01/2020
• Initial Report FDA Received Date: 03/20/2020
• Supplement Report FDA Received Date: 09/21/2020
• 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