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

Model Number M00513740

Device Problems Difficult or Delayed Positioning (1157); Material Deformation (2976); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Th 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 (b)(6) 2019 that an ultraflex esophageal ng distal release covered stent was to be used to treat patient's dysphagia due to malignant esophageal stricture during an upper gastrointestinal tract procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and more tightness was seen on the distal part of the esophagus near the lower esophageal sphincter (les).The patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, under fluoroscopy, the physician noticed that a portion of the stent bowed; when the stent was pulled it got coiled and looked a "u shaped" on fluoroscopy.Reportedly, the physician tried to straighten up the stent post deployment but it was not successful.The ultraflex esophageal stent was removed from the patient with rat tooth forceps and a different stent was placed to complete the procedure.There were no patient's complication reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

Block b5 has been updated with additional information received on july 19, 2019.Block h6: problem code 3009 captures the reportable event of stent positioning issue.Block h10: an ultraflex esophageal ng distal release covered stent and delivery system were received for analysis; the stent deployment suture was also returned.The stent was received deployed and expanded.The stent was measured to be within specifications.No issues with the device were noted.The complainant confirmed that the correct device was returned.However, as there was no issue with the returned device, the reported event could not be confirmed.The investigation concluded that most likely the reported event was due to anatomical or procedural factors such as characteristics of the lesion, handling of the device, the techniques used by the user, and normal procedural difficulties encountered during the procedure, which may have limited the performance of the device.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of the release for distribution.Block h11: block h6 (device codes) has been corrected based on the additional information received on july 19, 2019.

Event Description

It was reported to boston scientific corporation on may 26, 2019 that an ultraflex esophageal ng distal release covered stent was to be used to treat patient's dysphagia due to malignant esophageal stricture during an upper gastrointestinal tract procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tortuous and more tightness was seen on the distal part of the esophagus near the lower esophageal sphincter (les).The patient's anatomy was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, under fluoroscopy, the physician noticed that a portion of the stent bowed; when the stent was pulled it got coiled and looked a "u shaped" on fluoroscopy.Reportedly, the physician tried to straighten up the stent post deployment but it was not successful.The ultraflex esophageal stent was removed from the patient with rat tooth forceps and a different stent was placed to complete the procedure.There were no patient's complication reported as a result of this event.The patient's condition following the procedure was reported to be stable.Additional information received on july 19, 2019.According to the complainant, the ultraflex esophageal stent was not damaged.The stent buckled during deployment and was misplaced.An attempt was made to reposition the stent, at which point it became "u shaped", but it was not damaged.Reportedly, the stent was removed and another 15 cm ultraflex esophageal stent was placed.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Type of Device: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8708454
• MDR Text Key: 148322016
• Report Number: 3005099803-2019-03097
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• 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
• Report Date: 08/02/2019

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: 04/08/2020
• Device Model Number: M00513740
• Device Catalogue Number: 1374
• Device Lot Number: 0021962927
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2019
• Initial Date Manufacturer Received: 05/26/2019
• Initial Date FDA Received: 06/18/2019
• Supplement Dates Manufacturer Received: 07/16/2019
• Supplement Dates FDA Received: 08/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 64