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

Model Number	M00516910
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Obstruction of Flow (2423)
Health Effect - Clinical Codes	Discomfort (2330); No Code Available (3191)
Date of Event	12/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 december 13, 2019 that a wallflex esophageal partially covered stent was implanted to treat a 1.5 cm distal esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.Additionally 2-3 weeks later, the patient wanted the stent removed due to severe discomfort.According to the complainant, during the stent removal procedure, the physician had difficulty removing the stent from the patient due to normal tissue ingrowth.Reportedly, during the attempt removal, the stent retrieval loop broke and the stent was unable to be removed.The physician placed a fully covered stent within the initial stent and planned to remove the stent from the patient in a couple of weeks.On (b)(6) 2019, the stent was successfully removed using forceps.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: patient code 3191 captures the additional intervention to remove the stent.Problem code 2423 captures the reportable event of stent blocked/ occluded.Problem code 1069 captures the reportable event of stent suture was broken.Problem code 1528 captures the reportable event of stent difficult to remove.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.Block h11: block g4 in the initial report was filled in with (b)(6), 2019 in error, the correct date that boston scientific became aware of the event was (b)(6), 2019.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex esophageal partially covered stent was implanted to treat a 1.5 cm distal esophageal stricture during an esophageal stent placement procedure performed on (b)(6), 2019.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.Additionally 2-3 weeks later, the patient wanted the stent removed due to severe discomfort.According to the complainant, during the stent removal procedure, the physician had difficulty removing the stent from the patient due to normal tissue ingrowth.Reportedly, during the attempt removal, the stent retrieval loop broke and the stent was unable to be removed.The physician placed a fully covered stent within the initial stent and planned to remove the stent from the patient in a couple of weeks.On (b)(6), 2019, the stent was successfully removed using forceps.There were no patient complications reported as a result of this event.

• 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: 9572144
• Report Number: 3005099803-2019-06455
• Device Sequence Number: 438251
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K073266
• 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): 01/21/2020

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: 10/14/2021
• Device Model Number: M00516910
• Device Catalogue Number: 56453
• Device Lot Number: 0024596790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/17/2019
• Supplement Date Received by Manufacturer: 01/20/2020
• Initial Report FDA Received Date: 01/09/2020
• Supplement Report FDA Received Date: 01/21/2020
• 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