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

Model Number	M00516950
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/01/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal cancer during a stent placement procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was fully deployed and got bent into the tumor.In the physician's assessment the patient's tortuous anatomy contributed to the deformed stent inside the tumor.The stent was removed from the patient with forceps; however, as the stent was removed it grazed the esophagus which resulted in bleeding.The procedure was completed with another wallflex esophageal stent, which was also used as tamponade for the bleed, and no other intervention was performed to address the bleeding.The patient's condition at the conclusion of the procedure was reported to be good.
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: medical device problem code a0406 captures the reportable event of stent material deformation.Block h10: a fully deployed and expanded wallflex esophageal stent was received for analysis; the delivery system was not returned.The stent was inspected and no damages were noted.The reported event of stent material deformation was not confirmed as the stent was received fully deployed and expanded.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, bleeding (hemorrhage, minor) is noted within the ifu as a potential adverse event associated with the use of this device.It is most likely that the characteristics of the lesion and the patient's tortuous anatomy limited the performance of the device and contributed to the damaged stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.A ship history was unable to be performed as customer number was not available.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2022 that a wallflex esophageal partially covered stent was to be implanted to treat an esophageal cancer during a stent placement procedure performed on (b)(6), 2022.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent was fully deployed and got bent into the tumor.In the physician's assessment the patient's tortuous anatomy contributed to the deformed stent inside the tumor.The stent was removed from the patient with forceps; however, as the stent was removed it grazed the esophagus which resulted in bleeding.The procedure was completed with another wallflex esophageal stent, which was also used as tamponade for the bleed, and no other intervention was performed to address the bleeding.The patient's condition at the conclusion of the procedure was reported to be good.

• Brand Name: WALLFLEX ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14174920
• Report Number: 3005099803-2022-02108
• Device Sequence Number: 19839857
• Product Code: ESW
• UDI-Device Identifier: 08714729765295
• UDI-Public: 08714729765295
• Combination Product (Y/N): N
• Initial Reporter Country: CS
• PMA/510(K) Number: K073266
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2022

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 Model Number: M00516950
• Device Catalogue Number: 1695
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/01/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/21/2022
• Supplement Report FDA Received Date: 06/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female