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

Model Number	M00516910
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of (b)(6).Patient's weight was reported to be (b)(6), however, the unit of measurement was not reported.Initial reporter's phone number: (b)(6).(b)(4).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 or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal stenosis during an esophagogastroduodenoscopy (egd) with esophageal stent placement procedure performed on (b)(6) 2021.It was reported that during the procedure, resistance was felt at the pharynx when attempting to pass the stent on a guidewire.Under endoscopic visualization, it was noted that the soft tip of the introducer was detached.The stent was removed from the patient with the delivery system and another wallflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Additional Manufacturer Narrative
Block a1: patient's identifier is (b)(6).Blocks a2, a4, b5, e1 (initial reporters address), and h10 have been updated with additional information received on february 23, 2021.Block e1: initial reporter's phone number: (b)(6).Block h6: medical device problem code a0501 captures the reportable event of tip detached.Block h10: 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 or Problem Description
It was reported to boston scientific corporation on (b)(6)2021 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal stenosis during an esophagogastroduodenoscopy (egd) with esophageal stent placement procedure performed on (b)(6) 2021.It was reported that during the procedure, resistance was felt at the pharynx when attempting to pass the stent on a guidewire.Under endoscopic visualization, it was noted that the soft tip of the introducer was detached.The stent was removed from the patient with the delivery system and another wallflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.The device has not been received for analysis.Additional information received on february 23, 2021.It was reported that the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent did not reach the target lesion in the esophagus because the tip detached at the pharynx.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2021 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal stenosis during an esophagogastroduodenoscopy (egd) with esophageal stent placement procedure performed on (b)(6) 2021.It was reported that during the procedure, resistance was felt at the pharynx when attempting to pass the stent on a guidewire.Under endoscopic visualization, it was noted that the soft tip of the introducer was detached.The stent was removed from the patient with the delivery system and another wallflex esophageal stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.It was reported that the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent did not reach the target lesion in the esophagus because the tip detached at the pharynx.It was reported that a 0.0035 jagwire guidewire was used during the esophageal stent placement procedure.Note: per the wallflex esophageal partially covered stent system directions for use (dfu), the required size of the guidewire is 0.038 in (0.97mm).The user did not use the correct size of the guidewire as indicated in the dfu.
Additional Manufacturer Narrative
Block a1: patient's identifier is (b)(6).Block b1, b2 (outcomes attrib to adv event) and h1 have been updated.Blocks b5 and h6 (device code) has been updated with additional information received on may 10, 2021.Block e1: initial reporter's phone number: (b)(6).Block h6: medical device problem code a0501 captures the reportable event of tip detached.Block h10: a wallflex partially covered esophageal stent and delivery system were returned for analysis.The stent was received fully covered and undeployed.Visual examination of the returned device found the tip of the device was detached.The detached tip was returned.The outer blue sheath was accordioned.No other issues with the stent and delivery system were noted.The reported event of tip detached was confirmed during the visual examination.A labeling review was performed, and from the information available, the device was used in a manner inconsistent with the instructions for use.The ifu cited: "caution: a stiff bodied 0.038 in (0.97 mm)guidewire with a floppy tip is recommended to facilitate passage through tortuous anatomy".A 0.0035 in guidewire was used.The investigation concluded that the reported event and the observed failure were likely due to factors encountered during the procedure.It may be that the interaction of the device with the scope, and/or the use of an incorrect guidewire could have contributed to the resistance felt while attempting to pass the stent on the guidewire leading to insufficient stiffness and could have caused the detachment of the tip and the damage on the outer sheath.Therefore, the event is classified as failure to follow instructions.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 ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11358824
• Report Number: 3005099803-2021-00643
• Device Sequence Number: 14298694
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: 08714729765257
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2021

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: 07/24/2022
• Device Model Number: M00516910
• Device Catalogue Number: 1691
• Device Lot Number: 0025763028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 01/29/2021
• Supplement Date Received by Manufacturer: 02/23/2021; 05/10/2021
• Initial Report FDA Received Date: 02/22/2021
• Supplement Report FDA Received Date: 03/17/2021; 06/01/2021
• 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: 63 YR
• Patient Weight: 50