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

Model Number	M00513840
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex esophageal ng proximal release covered stent was to be used in the jejunum during an esophageal stenting procedure performed on (b)(6) 2019.Reportedly, the patient had a "not total gastrectomy" prior to stent placement.According to the complainant, a week before this esophageal stenting procedure, a prior ultraflex esophageal stent had been implanted.However, another stenosis was noted behind (at the distal end of) the prior implanted stent.There were no issues with the prior implanted stent.On (b)(6) 2019, during the stent placement procedure, the stent was deployed partially and was able to cover 10 cm of the area of the stenosis.By the time the deployment suture was about to finish, the stent deployment suture became stuck.The physician forcibly pulled the deployment suture, and it snapped/separated, and it was unable to continue deploying the stent.The physician tried to expose the suture by cutting the proximal side of the delivery system, but it was unable to find the suture.Reportedly, the physician attempted to separate the delivery system from the stent lumen by burning the stent tip with argon plasma, but the stent lumen would not separate from the delivery system.Eventually, the physician grasped the proximal side of the stent that was already deployed with grasping forceps and was able to remove the stent and delivery system out from the patient.The procedure was completed with a different device.There were no adverse effect to the patient as a result of this event.Note: according to the complainant, the ultraflex esophageal ng proximal covered stent was implanted in the jejunum and the patient had a "not total gastrectomy probably".Per the ultraflex esophageal covered stent dfu, the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/ or extrinsic malignant tumors only.The ultraflex covered esophageal ng stent system is also indicated for occlusion of concurrent esophageal fistula.The ultraflex esophageal covered stent is contraindicated for placement in an esophago-jejunostomy (following gastrectomy), as peristalsis may displace stent.
Event or Problem Description
It was reported to boston scientific corporation on june 21, 2019 that an ultraflex esophageal ng proximal release covered stent was to be used in the jejunum during an esophageal stenting procedure performed on (b)(6) 2019.Reportedly, the patient had a "not total gastrectomy" prior to stent placement.According to the complainant, a week before this esophageal stenting procedure, a prior ultraflex esophageal stent had been implanted.However, another stenosis was noted behind (at the distal end of) the prior implanted stent.There were no issues with the prior implanted stent.On (b)(6) 2019, during the stent placement procedure, the stent was deployed partially and was able to cover 10 cm of the area of the stenosis.By the time the deployment suture was about to finish, the stent deployment suture became stuck.The physician forcibly pulled the deployment suture, and it snapped/separated, and it was unable to continue deploying the stent.The physician tried to expose the suture by cutting the proximal side of the delivery system, but it was unable to find the suture.Reportedly, the physician attempted to separate the delivery system from the stent lumen by burning the stent tip with argon plasma, but the stent lumen would not separate from the delivery system.Eventually, the physician grasped the proximal side of the stent that was already deployed with grasping forceps and was able to remove the stent and delivery system out from the patient.The procedure was completed with a different device.There were no adverse effect to the patient as a result of this event.Note: according to the complainant, the ultraflex esophageal ng proximal covered stent was implanted in the jejunum and the patient had a "not total gastrectomy probably".Per the ultraflex esophageal covered stent dfu, the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/ or extrinsic malignant tumors only.The ultraflex covered esophageal ng stent system is also indicated for occlusion of concurrent esophageal fistula.The ultraflex esophageal covered stent is contraindicated for placement in an esophago-jejunostomy (following gastrectomy), as peristalsis may displace stent.
Additional Manufacturer Narrative
Block e1: initial reporter's city, state, and zip code: (b)(6).Block h6: problem code 2906 captures the reportable event of partially deployed ultraflex esophageal ng proximal release covered stent.Problem code 1069 captures the reportable event of deployment suture broken on an ultraflex esophageal ng proximal release covered stent.Block h10: an ultraflex esophageal ng proximal release covered stent and delivery system were received for analyisis.Visual examination of the returned device found the stent was received partially deployed.The stent was unraveled and one of the green retention sutures was broken.The black deployment suture was also found broken.The tip and handle of the delivery system were detached and were not returned.There were kinks noted along the shaft.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received however, it was possible to manually deploy the stent by pulling directly on the deployment suture.The stent was measured to be within specification.No other issues with the stent and delivery system were noted.The damage to the stent deployment suture was consistent with the application of excessive force during attempted deployment.The unraveling of the stent, broken stent retention suture, and kinks in the shaft may have happened due to manipulation, excessive handling or resistance encountered during the procedure.The detachment of the tip and handle are consistent with the complainant's report that the delivery system was cut.Taking all available information into consideration, the investigation concluded that most likely the observed failures and the reported events were due to procedural factors such as handling of the device, the technique 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 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 ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/ or extrinsic malignant tumors only.The ultraflex covered esophageal ng stent system is also indicated for occlusion of concurrent esophageal fistula.The ultraflex esophageal covered stent is contraindicated for placement in an esophago-jejunostomy (following gastrectomy), as peristalsis may displace stent".Reportedly, the ultraflex esophageal ng proximal covered stent was implanted in the jejunum and the patient had a "not total gastrectomy probably".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 release for distribution.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8795202
• Report Number: 3005099803-2019-03645
• Device Sequence Number: 11262380
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/13/2020
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0022935936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2019
• Initial Date Received by Manufacturer: 06/21/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 07/16/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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
• Patient Age: 75 YR