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

Model Number M00565010

Device Problems Difficult or Delayed Positioning (1157); Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the stent remains implanted and is not available for return.If any further relevant information is received, a supplement mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex duodenal stent has been implanted to treat a 3/4 cm malignant stricture in the duodenum during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during procedure, the stent was attempted to be deployed, however, there was difficulty fully deploying the stent.When the outer sheath was manually pulled and the stent was deployed but was not in the target location.Reportedly, the physician left the stent in place and a larger duodenal stent (9 cm) was implanted to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be fine.

Manufacturer Narrative

According to the complainant, the stent remains implanted and is not available for return.If any further relevant information is received, a supplement mdr will be filed.(model #), and (premarket/510(k)#) have been corrected.The stent remains implanted and will not be available for return.

Event Description

It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex duodenal stent has been implanted to treat a 3/4 cm malignant stricture in the duodenum during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during procedure, the stent was attempted to be deployed, however, there was difficulty fully deploying the stent.When the outer sheath was manually pulled and the stent was deployed but was not in the target location.Reportedly, the physician left the stent in place and a larger duodenal stent (9 cm) was implanted to complete the procedure.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 7785591
• MDR Text Key: 117187994
• Report Number: 3005099803-2018-60041
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• 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: 09/24/2018

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: 04/15/2020
• Device Model Number: M00565010
• Device Catalogue Number: 56436
• Device Lot Number: 0021991832
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/23/2018
• Initial Date FDA Received: 08/15/2018
• Supplement Dates Manufacturer Received: 08/28/2018
• Supplement Dates FDA Received: 09/24/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention