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

Model Number	M00565010
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
Additional 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 or Problem 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
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7785591
• Report Number: 3005099803-2018-60041
• Device Sequence Number: 173766
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K062750
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 07/23/2018
• Supplement Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 09/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention