MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ ENTERAL ENDOPROSTHESIS; STENT, COLONIC, METALIC, EXPANDABLE

Model Number M00565590

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, 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 mdr will be filed.

Event Description

It was reported to boston scientific corporation on (b)(6), 2015 that a wallstent enteral stent was to be used in the intestinal tract during a stent implantation procedure performed on (b)(6), 2015.According to the complainant, this was to treat an intestinal obstruction.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the preparation, the physician tested the delivery system outside of the patient if it could be pulled as it normally would, only to find out that the braided part of the stent was split.The device was not used and the procedure was completed with another of the same device.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

Investigation results: a wallflex enteral duodenal stent was returned for analysis.Visual examination of the returned device found that the wires at the flare end of the stent were uncrossed and damaged.The type of damage noted is consistent with a resistance being met during deployment.No other damage was present along the stent.Device analysis determined that the condition of the returned device was consistent with the complaint incident.However, the stent was fully deployed when returned.The noted defect likely occurred due to handling of the device or portion of the device without direct patient contact either during unpacking, preparation, or shipping.Therefore, the most probable root cause is handling damage.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation on september 28, 2015 that a wallstent enteral stent was to be used in the intestinal tract during a stent implantation procedure performed on (b)(6) 2015.According to the complainant, this was to treat an intestinal obstruction.Reportedly, the patient's anatomy was not tortuous and was not pre dilated.During the preparation, the physician tested the delivery system outside of the patient if it could be pulled as it normally would, only to find out that the braided part of the stent was split.The device was not used and the procedure was completed with another of the same device.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: WALLSTENT¿ ENTERAL ENDOPROSTHESIS
• Type of Device: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 5166195
• MDR Text Key: 28872701
• Report Number: 3005099803-2015-02982
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K000281
• 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
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/04/2017
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 17673688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/28/2015
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2015
• 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 Age: 70 YR
• Patient Weight: 74