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

Catalog Number 56027

Device Problems Use of Device Problem (1670); Obstruction of Flow (2423); Material Integrity Problem (2978)

Patient Problem No Code Available (3191)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt, and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on december 11, 2018 that an ultraflex esophageal ng distal release uncovered stent was implanted to treat an esophageal perforation in a boerhaave syndrome during an esophageal stent placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the stent was implanted in a satisfactory position.Reportedly, post stent placement, c-reactive protein (crp) has increased and the drain has started to produce again.On (b)(6) 2018, the utraflex esophageal stent was removed from the patient, and noticed there were tissues on the covered area protruded through the meshes of the stent lumen.A different device was used to complete the procedure.Five days post stent removal, it was reported that a large portion of the stent cover has disappeared and seemed like it was "digested".A photo of the device confirmed that the stent cover was damaged.Note: according to the complainant, the ultraflex esophageal stent was implanted to treat an esophageal perforation in a boerhaave syndrome.However, per the ultraflex esophageal ng uncovered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophagus strictures caused by intrinsic and/ or extrinsic malignant tumors only.

Manufacturer Narrative

Device manufacture date; the complainant was unable to report the suspect device upn and lot number; therefore, the manufacture and expiration dates are unknown.Problem code 2978 captures the reportable event of stent cover damaged.An ultraflex esophageal stent was received for analysis; the delivery system was not returned.Visual analysis of the returned device found the stent cover was damaged (torn)and with some tissue residues present on the stent.The stent was measured to be within specifications.No other issues were noted.Device analysis determined that the condition of the returned device was consistent with the reported event of stent cover damaged.Labeling review was performed and, from the information available, this device was used in a manner inconsistent with the labeled indication.The dfu indicates, "the ultraflex esophageal covered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophagus strictures caused by intrinsic and/ or extrinsic malignant tumors only".However, the stent was implanted intra-operatively to treat an esophageal perforation repair due to boerhaave syndrome.The placement of the stent to treat boerhaave's syndrome may have put the stent in contact with gastric content, which could have damaged the stent cover during indwell.The dfu also indicates, "the ultraflex esophageal stent system is not intended to be moved or removed once it is deployed.Moving the deployed stent may break the stent wire or dislodge the cover.If it is necessary to move or remove the stent, it should be done only during the initial stent placement procedure and prior to balloon dilatation using an atraumatic retrieval device to grasp the suture threaded around the stent".Although the complainant reported the stent cover was already damaged while in position, the removal of stent may have contributed further damage since the stent is not designed to be removed after the initial placement.Taking all available information into consideration, the investigation concluded that the most probable root cause is cause traced to intentional off-label, unapproved or contraindicated use.A device history record (dhr) review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr review on the most probable lots did not identify any deviations within manufacturing/ service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation on december 11, 2018 that an ultraflex esophageal covered stent was implanted to treat an esophageal perforation in a boerhaave syndrome during an esophageal stent procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the stent was implanted in a satisfactory position.Reportedly, post stent placement, c-reactive protein (crp) has increased and the drain has started to produce again.On (b)(6) 2018, the ultraflex esophageal stent was removed from the patient, and noticed there were tissues on the covered area protruded through the meshes of the stent lumen.A different device was used to complete the procedure.Five days post stent removal, it was reported that a large portion of the stent cover has disappeared and seemed like it was "digested".A photo of the device confirmed that the stent cover was damaged.Note: according to the complainant, the ultraflex esophageal stent was implanted to treat an esophageal perforation in a boerhaave syndrome.However, per the ultraflex esophageal covered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophagus strictures caused by intrinsic and/or extrinsic malignant tumors only.Additional information received on january 09, 2019, according to the complainant, the patient's defect due to boerhaave's syndrome was 2cm in size.The stent was removed on (b)(6) 2018, 5 days post stent placement due to gastric content present in the patient's thoracic drain, as well as deterioration of the patient's clinical situation.The stent was removed by pulling the upper stent wire with forceps.Reportedly, it was observed that the stent cover was partially gone while the stent was in position and the tissue protruded through the mesh of the stent in the lumen.The complainant reported that the period of 5 days was too short for real ingrowth.Additional information received on january 17, 2019, according to the complainant, the stent was placed at the end of surgery, when the mediastinum was cleaned and 2 mediastinal drains were placed.Reportedly, the patient was placed in intensive care after stent placement.On (b)(6) 2018, it was reported that the infection parameters had decreased and the drains had stopped producing.However, in the afternoon of on (b)(6) 2018, one of the drains started to produce again.On (b)(6) 2018, the drain product had increased with a biliary aspect, and the infection parameter c -reactive protein (crp) started rising again.A computed tomography (ct) scan was performed with oral contrast and showed the contrast leaked through the perforation towards the drain.This prompted a gastroscopy procedure which showed the stent cover had disappeared at different spots.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that an ultraflex esophageal covered stent was implanted to treat an esophageal perforation in a boerhaave syndrome during an esophageal stent placement procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the stent was implanted in a satisfactory position.Reportedly, post stent placement, c-reactive protein (crp) has increased and the drain has started to produce again.On (b)(6) 2018, the utraflex esophageal stent was removed from the patient, and noticed there were tissues on the covered area protruded through the meshes of the stent lumen.A different device was used to complete the procedure.Five days post stent removal, it was reported that a large portion of the stent cover has disappeared and seemed like it was "digested".A photo of the device confirmed that the stent cover was damaged.Note: according to the complainant, the ultraflex esophageal stent was implanted to treat an esophageal perforation in a boerhaave syndrome.However, per the ultraflex esophageal covered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophagus strictures caused by intrinsic and/ or extrinsic malignant tumors only.

Manufacturer Narrative

Problem code 2423 captures the reportable event of stent obstruction within device problem code 2978 captures the reportable event of stent cover damaged.The device has not been received for analysis.Upon receipt, and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation on december 11, 2018 that an ultraflex esophageal covered stent was implanted to treat an esophageal perforation in a boerhaave syndrome during an esophageal stent procedure performed on (b)(6) 2018.According to the complainant, on (b)(6) 2018, the stent was implanted in a satisfactory position.Reportedly, post stent placement, c-reactive protein (crp) has increased and the drain has started to produce again.On (b)(6) 2018, the ultraflex esophageal stent was removed from the patient, and noticed there were tissues on the covered area protruded through the meshes of the stent lumen.A different device was used to complete the procedure.Five days post stent removal, it was reported that a large portion of the stent cover has disappeared and seemed like it was "digested".A photo of the device confirmed that the stent cover was damaged.Note: according to the complainant, the ultraflex esophageal stent was implanted to treat an esophageal perforation in a boerhaave syndrome.However, per the ultraflex esophageal covered stent system directions for use, the stent is intended for maintaining esophageal luminal patency in esophagus strictures caused by intrinsic and/or extrinsic malignant tumors only.Additional information received on january 09, 2019.According to the complainant, the patient's defect due to boerhaave's syndrome was 2cm in size.The stent was removed on (b)(6) 2018, 5 days post stent placement due to gastric content present in the patient's thoracic drain, as well as deterioration of the patient's clinical situation.The stent was removed by pulling the upper stent wire with forceps.Reportedly, it was observed that the stent cover was partially gone while the stent was in position and the tissue protruded through the mesh of the stent in the lumen.The complainant reported that the period of 5 days was too short for real ingrowth.Additional information received on january 17, 2019.According to the complainant, the stent was placed at the end of surgery, when the mediastinum was cleaned and 2 mediastinal drains were placed.Reportedly, the patient was placed in intensive care after stent placement.On (b)(6) 2018, it was reported that the infection parameters had decreased and the drains had stopped producing.However, in the afternoon of (b)(6) 2018, one of the drains started to produce again.On (b)(6) 2018, the drain product had increased with a biliary aspect, and the infection parameter c -reactive protein (crp) started rising again.A computed tomography (ct) scan was performed with oral contrast and showed the contrast leaked through the perforation towards the drain.This prompted a gastroscopy procedure which showed the stent cover had disappeared at different spots.

Manufacturer Narrative

B5 has been updated with the additional information received on january 09, 2019 and january 17, 2019.The complainant was unable to report the suspect device upn and lot number; therefore, the manufacture and expiration dates are unknown.Problem code 2978 captures the reportable event of stent cover damaged.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.D7 and h6 have been corrected based on the additional information received on january 09, 2019 and january 17, 2019.

• 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: 8226094
• MDR Text Key: 132353006
• Report Number: 3005099803-2018-62411
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• PMA/PMN Number: K091816
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 56027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Date Manufacturer Received: 02/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention