MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565030

Device Problems Premature Activation (1484); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/19/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).According to the complainant, the stent remains implanted but the delivery system will be available for return.However, the device has not 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 medwatch will be filed.

Event Description

Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-01145 for the associated device information.It was reported to boston scientific corporation on february 25, 2021 that two wallflex duodenal stents were implanted to treat a malignant pancreatic head mass causing extrinsic pressure in the duodenum during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient had a metastatic pancreas cancer and gastric outlet obstruction.Reportedly, the patient had two duodenal stenoses; one at brand name/common device name junction and the other at procode/manufacturer junction.During the procedure, a stiff wallstent guidewire was passed, and the 22x120 mm uncovered wallflex duodenal stent (the subject of this report) deployed prematurely and was placed more proximal.The fully expanded stent seemed much shorter than a 12 cm stent visualized endoscopicaly and fluoroscopically.The stent was measured to be 6 cm.A second wallflex duodenal stent with a stent size of 22x 90 mm stent ( the subject of mfr.Report# 3005099803-2021-01145 ) was deployed.The stent deployed prematurely and was placed more proximal.The stent seemed much shorter than a 9 cm stent.The stents remain implanted and another wallflex stent was placed to complete the procedure.The physician was comfortable leaving the stents in place.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to one of the two devices used during the same procedure.Refer to manufacturer report # 3005099803-2021-01145 for the associated device information.It was reported to boston scientific corporation on february 25, 2021 that two wallflex duodenal stents were implanted to treat a malignant pancreatic head mass causing extrinsic pressure in the duodenum during an esophagogastroduodenoscpopy (egd) with stent placement procedure performed on (b)(6) 2021.Reportedly, the patient had a metastatic pancreas cancer and gastric outlet obstruction.Reportedly, the patient had two duodenal stenoses; one at d1/d2 junction and the other at d2/d3 junction.During the procedure, a stiff wallstent guidewire was passed, and the 22x120 mm uncovered wallflex duodenal stent (the subject of this report) deployed prematurely and was placed more proximal.The fully expanded stent seemed much shorter than a 12 cm stent visualized endoscopicaly and fluoroscopically.The stent was measured to be 6 cm.A second wallflex duodenal stent with a stent size of 22x 90 mm stent ( the subject of mfr.Report# 3005099803-2021-01145 ) was deployed.The stent deployed prematurely and was placed more proximal.The stent seemed much shorter than a 9 cm stent.The stents remain implanted and another wallflex stent was placed to complete the procedure.The physician was comfortable leaving the stents in place.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block e1: second physician involved in the procedure: dr.(b)(6).Block h6: medical device problem code a150103 captures the reportable event of stent prematurely deployed.Medical device problem code a0203 captures the reportable event of stent shorter than the labeled length.Block h10: a wallflex duodenal delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the inner sheath and outer blue sheath were kinked.No other issues with the device were noted.The damages noted of the returned device were most likely due to operational factors encountered during the procedure.It might be that the techniques used by the user during insertion or withdrawal of the device through the scope or anatomical factors could have contributed to an increase in resistance when the device was advanced through the patient causing the user to apply more force, leading to the observed kinks in the inner and outer sheath.However, the reported event of stent size incorrect and stent premature deployment were not confirmed; there is no indication of what the customer reported because the stent was not returned.The investigation concluded that, without analysis of the device, there is a lack of objective evidence or descriptive conditions of the event required to determine a probable root cause of the event.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: WALLFLEX DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11516249
• MDR Text Key: 240662222
• Report Number: 3005099803-2021-01144
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456506
• UDI-Public: 08714729456506
• Combination Product (y/n): N
• PMA/PMN Number: K062750
• 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: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2022
• Device Model Number: M00565030
• Device Catalogue Number: 6503
• Device Lot Number: 0025251586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 02/25/2021
• Initial Date FDA Received: 03/18/2021
• Supplement Dates Manufacturer Received: 03/30/2021
• Supplement Dates FDA Received: 04/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 47 YR