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

Device Problems Use of Device Problem (1670); Component Missing (2306); Obstruction of Flow (2423)

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

Event Date 10/21/2019

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.According to the complainant the stent was implanted at (b)(6).(b)(4).The complainant indicated that the suspect 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex esophageal uncovered stent has been implanted to treat a leak in the esophagus during a gastroscopy with stent placement procedure performed approximately 3 months earlier.According to the complainant, on (b)(6) 2019, three (3) months post stent placement, the patient presented with discomfort.A gastroscopy procedure was performed and the stent was found to have tissue ingrowth along its length.Reportedly, the physician planned to bring the patient back to remove the stent on (b)(6) 2019.Despite efforts, boston scientific has been unable to confirm if the stent was successfully removed.The patient's condition at the conclusion of the procedure was reported to be stable and the event was reported to be resolved.Note: according to the complainant, the ultraflex esophageal uncovered distal release stent was placed to treat leak.However, per ultraflex esophageal ng stent system directions for use, the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.

Manufacturer Narrative

Blocks b5, d7, h6 and h10 have been updated with additional information received on november 14, 2019, december 01, 2019 and december 05, 2019.Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number.Therefore, the manufacture and expiration dates are unknown.Block e1: according to the complainant the stent was implanted at cairns base hospital by dr.(b)(6).Block h6: problem code 2423 captures the reportable event of stent blocked/ occluded.Problem code 2306 captures the reportable event of stent cover missing.Patient code 3191 is being used to capture the additional intervention to remove the stent.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 Description

It was reported to boston scientific corporation on october 22, 2019 that an ultraflex esophageal uncovered stent has been implanted to treat a leak in the esophagus during a gastroscopy with stent placement procedure performed approximately 3 months earlier.According to the complainant, on october 21, 2019, three (3) months post stent placement, the patient presented with discomfort.A gastroscopy procedure was performed and the stent was found to have tissue ingrowth along its length.Reportedly, the physician planned to bring the patient back to remove the stent on (b)(6) 2019.Despite efforts, boston scientific has been unable to confirm if the stent was successfully removed.The patient's condition at the conclusion of the procedure was reported to be stable and the event was reported to be resolved.Note: according to the complainant, the ultraflex esophageal uncovered distal release stent was placed to treat leak.However, per ultraflex esophageal ng stent system directions for use, the stent is indicated for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.Additional information received on november 14, 2019.According to the complainant, during the scheduled stent removal procedure on (b)(6) 2019, the stent was found to still have tissue in growth so another stent was implanted through it.Additional information received on december 01, 2019 and december 05, 2019.According to the complainant, the stent was successfully removed from the patient on (b)(6) 2019 using an overtube and rat tooth grasping forceps.Additionally, it was reported that the stent was originally placed to treat a post-surgical gastric sleeve leak.The original implanting physician clarified that the stent was not an uncovered stent at implantation.The stent was believed to be a covered stent when originally placed.The lack of a stent covering was not noticed during the index procedure.

• Brand Name: ULTRAFLEX ESOPHAGEAL
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9323496
• MDR Text Key: 166998626
• Report Number: 3005099803-2019-05567
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K955347
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention