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

Model Number M00565590

Device Problems Break (1069); Material Perforation (2205); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Investigation result of stent partially deployed.Investigation result of stent broken.Investigation result of stent wire perforation in the sheath.Investigation results: a wallstent enteral stent and delivery system were returned for analysis.Visual examination of the returned device found that the stent was partially deployed with the stent wires perforating through the exterior tube at the distal end of the device.During the product analysis, the investigator was able to deploy the stent with difficulty.It was noted that there was a large amount of bodily fluid on the deployed stent.The stent wires were severely damaged due to the perforation through the outer sheath.The stent wires at both distal and the proximal side of the stent were broken and loose.The damage identified is consistent with the application of excessive force being applied to the delivery system.A visual and microscopic examination found no issue with the stent holder or the stent cup.No other issues were identified during the product analysis.Device analysis determined that the condition of the returned device was not consistent with the complaint incident as the stent was received partially deployed.The noted damage to the returned device were consistent with excessive force being applied during deployment and are likely due to anatomical or procedural factors such as tortuous anatomy or maneuvering of the device.Therefore, a review and analysis of all available information indicated that the most probable root cause is operational context.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 (b)(6) 2015 that a wallstent enteral stent was used in the duodenum during a stenting procedure performed on (b)(6) 2015.According to the complainant, the patient had cancer.During the procedure, the stent was not released.The procedure was not completed due to this event.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.Despite numerous attempts, boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 5399123
• MDR Text Key: 37139965
• Report Number: 3005099803-2016-00203
• Device Sequence Number: 1
• Product Code: MQR
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K000281
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2016

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: Physician
• Device Expiration Date: 08/19/2016
• Device Model Number: M00565590
• Device Catalogue Number: 6559
• Device Lot Number: 17212978
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2016
• Initial Date FDA Received: 01/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/26/2014
• 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: 67 YR
• Patient Weight: 72