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

Model Number M00565020

Device Problem Migration (4003)

Patient Problem Discomfort (2330)

Event Date 09/13/2019

Event Type  Injury  

Manufacturer Narrative

(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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on september 19, 2019 that a wallflex duodenal stent was implanted to treat a malignant duodenal stenosis during a stent placement procedure performed on (b)(6) 2019.According to the complainant, on (b)(6) 2019, the patient came back to the hospital and presented with discomfort.The physician performed magnetic resonance imaging (mri) and confirmed that the stent has migrated.The stent was removed and another wallflex duodenal stent was placed to treat patient's discomfort and the procedure was completed.The patient's current condition was reported to be fine.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that a wallflex duodenal stent was implanted to treat a malignant duodenal stenosis during a stent placement procedure performed on (b)(6) 2019.According to the complainant, on (b)(6) 2019, the patient came back to the hospital and presented with discomfort.The physician performed magnetic resonance imaging (mri) and confirmed that the stent has migrated.The stent was removed and another wallflex duodenal stent was placed to treat patient's discomfort and the procedure was completed.The patient's current condition was reported to be fine.

Manufacturer Narrative

Problem code 4003 captures the reportable event of stent migration.A wallflex duodenal stent was received for analysis; the delivery system was not returned.The stent was received deployed and expanded.Visual examination of the returned device did not find any damages or issues to the stent.The stent was measured to be within specifications.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Additionally, the event reported of stent migration and discomfort are noted within the dfu as potential adverse events associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.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: 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: 9180217
• MDR Text Key: 162011369
• Report Number: 3005099803-2019-04969
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456490
• UDI-Public: 08714729456490
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2020
• Device Model Number: M00565020
• Device Catalogue Number: 6502
• Device Lot Number: 0022324548
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2019
• Initial Date Manufacturer Received: 09/19/2019
• Initial Date FDA Received: 10/11/2019
• Supplement Dates Manufacturer Received: 11/12/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 145