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

Model Number M00565020

Device Problem Activation Failure (3270)

Patient Problem No Code Available (3191)

Event Date 04/07/2019

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).Explant date- (b)(6) 2019 (date unknown).(b)(4).According to the complainant, the suspect device has been retained and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation on august 8, 2019 that a wallfex duodenal stent was implanted to treat a malignant duodenal stricture during a duodenal stent implantation procedure performed on (b)(6) 2019.Reportedly, the patient had experienced vomiting prior to stent implantation and the patient's anatomy was dilated prior to stent placement procedure.According to the complainant, on (b)(6) 2019, the patient experienced a recurrence of vomiting.On (b)(6) 2019, an imaging was done and it was noticed that the stent had not fully expanded.In (b)(6) 2019 (exact date unknown), gastroenterostomy was performed and the stent was successfully removed from the patient.Reportedly, vomiting was resolved.The patient was able to drink a little water however, still unable to eat solid food.

Event Description

It was reported to boston scientific corporation on (b)(6) 2019 that a wallfex duodenal stent was implanted to treat a malignant duodenal stricture during a duodenal stent implantation procedure performed on (b)(6), 2019.Reportedly, the patient had experienced vomiting prior to stent implantation and the patient's anatomy was dilated prior to stent placement procedure.According to the complainant, on (b)(6) 2019, the patient experienced a recurrence of vomiting.On (b)(6) 2019, an imaging was done and it was noticed that the stent had not fully expanded.In (b)(6) 2019 (exact date unknown), gastroenterostomy was performed and the stent was successfully removed from the patient.Reportedly, vomiting was resolved.The patient was able to drink a little water however, still unable to eat solid food.***additional information received on september 9, 2019*** it was initially reported that the stent was removed during a gastroenterostomy procedure; however, according to the complainant, the name of the surgery to remove the stent coul not be confirmed.

Manufacturer Narrative

Blocks a1, a2, and a3 have been updated with additional information received on august 26, 2019.Block b5 has been updated with additional information received on (b)(6) 2019.Block e1: initial reporter address :(b)(6).Lock d7: explant date- (b)(6) 2019 (date unknown) block h6: problem code 3270 captures the reportable event of stent failed to expand.Patient code 3191 captures the surgical procedure (gastroenterostomy) performed to remove the stent.Conclusion code 4316 is being used in lieu of an adequate conclusion for device not returned.Block h10: according to the complainant, the suspect device has been retained and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: blocks d4 (lot number, expiration date), and e1(initial reporter's name), and h4 (device manufacture date) have been corrected based on corrected information received on august 26, 2019.

• 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: 8946032
• MDR Text Key: 156922602
• Report Number: 3005099803-2019-04261
• 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: 09/20/2019

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?: No
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/29/2019
• Supplement Dates Manufacturer Received: 08/26/2019
• Supplement Dates FDA Received: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR