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

Model Number M00516910

Device Problems Break (1069); Difficult to Remove (1528); Obstruction of Flow (2423)

Patient Problems Discomfort (2330); No Code Available (3191)

Event Date 12/13/2019

Event Type  Injury  

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 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.

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 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
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9572144
• MDR Text Key: 174519802
• Report Number: 3005099803-2019-06455
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (y/n): N
• PMA/PMN Number: K073266
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 01/09/2020
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention