MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT-UNI¿ ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number M001731380

Device Problems Migration or Expulsion of Device (1395); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/27/2016

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr.: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent failure to expand and stent migration occurred.The target lesion was located in the biliary artery.After a 0.035 non-bsc guidewire crossed the lesion, a 10mmx94mmx75cm wallstent-uni¿ endoprosthesis was advanced to treat the lesion.However, during procedure after deployment, the stent did not release from the shaft pusher and during withdrawal of the pusher, the stent migrated.The whole system was removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr.: the device and stent was still attached to the introducer sheath upon return.The stent was partially deployed by 15mm.The stent was removed from the introducer sheath and no issues were noted with its profile.A visual and tactile examination of the returned device found that the outer shaft was kinked 230mm from the base of the t-connector.This damage is consistent with excessive force being applied to the delivery system.The shaft outer diameter (od) was measured and is within specification.There were no issues with the profile of the tip.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).

Event Description

It was reported that stent failure to expand and stent migration occurred.The target lesion was located in the biliary artery.After a 0.035 non-bsc guidewire crossed the lesion, a 10mmx94mmx75cm wallstent-uni¿ endoprosthesis was advanced to treat the lesion.However, during procedure after deployment, the stent did not release from the shaft pusher and during withdrawal of the pusher, the stent migrated.The whole system was removed from the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient's status was good.

• Brand Name: WALLSTENT-UNI¿ ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 5457639
• MDR Text Key: 38962906
• Report Number: 2134265-2016-00992
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K992510
• 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: 01/27/2016

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: 06/30/2017
• Device Model Number: M001731380
• Device Catalogue Number: 73-138
• Device Lot Number: 0018153005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2016
• Initial Date FDA Received: 02/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/03/2015
• 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 Outcome(s): Required Intervention
• Patient Age: 50 YR