MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX ¿ DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number M00565010

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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

It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex duodenal stent was implanted to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent, however, an extra 6¿ long wire was noted to have fallen inside the patient.The physician stated there was a small tug during deployment but not what he would expect would break a wire.It is unknown if the wire came off the stent or out of the delivery system.Reportedly, it was confirmed that the duodenal stent and the delivery system appeared intact and not visibly damaged or broken.The stent remains implanted and the detached wire was retrieved from the patient.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.

Manufacturer Narrative

A broken segment of stent was received for analysis; the delivery system was not returned.The investigation concluded that the damage to the device was most likely due to anatomical/ procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on (b)(6), 2017 that a wallflex duodenal stent was implanted to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent, however, an extra 6¿ long wire was noted to have fallen inside the patient.The physician stated there was a small tug during deployment but not what he would expect would break a wire.It is unknown if the wire came off the stent or out of the delivery system.Reportedly, it was confirmed that the duodenal stent and the delivery system appeared intact and not visibly damaged or broken.The stent remains implanted and the detached wire was retrieved from the patient.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.

Manufacturer Narrative

Updated investigation results.A broken segment of wire was received for analysis; the delivery system was not returned.Visual examination of the returned broken wire found evidence of welding in one side of its loop.Some kinks were found along the wire.The wire was compared to another wallflex enteral stent with the same upn and found that its color and shape did match to a wallflex enteral stent.The wire was measured and its dimensions match with a wallflex enteral stent wire.No other issues with the device were noted.Although it was reported that there was no visible damage or broken parts of the device, the analysis revealed that the returned wire belongs to a wallflex enteral stent.The investigation concluded that the damage to the device was most likely due to anatomical/ procedural factors encountered during the procedure which limited the performance of the device, and that severe manipulation while trying to deploy or even retract the stent likely caused the wire to break.Per the investigation, in order to unbraid this wire from the stent, force/severe manipulation is required.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu) / product label.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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

Event Description

It was reported to boston scientific corporation on december 8, 2017 that a wallflex duodenal stent was implanted to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent, however, an extra 6¿ long wire was noted to have fallen inside the patient.The physician stated there was a small tug during deployment but not what he would expect would break a wire.It is unknown if the wire came off the stent or out of the delivery system.Reportedly, it was confirmed that the duodenal stent and the delivery system appeared intact and not visibly damaged or broken.The stent remains implanted and the detached wire was retrieved from the patient.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.

• Brand Name: WALLFLEX ¿ DUODENAL
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7157753
• MDR Text Key: 96163395
• Report Number: 3005099803-2017-03997
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K062750
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2017

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: 06/23/2019
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 20806476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 02/07/2018; 03/09/2018
• Supplement Dates FDA Received: 03/07/2018; 04/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/26/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention