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

Model Number M001731640

Device Problems Migration or Expulsion of Device (1395); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2014

Event Type  Injury  

Event Description

It was reported that stent migration occurred.Vascular access was obtained via the radial and femoral artery.The totally occluded, 160mm in length, eccentric target lesion was located in the non-tortuous and moderately calcified and 6mm in diameter superior vena cava (svc).A 22 x 70mm x 75cm wallstent-uni¿ endoprosthesis stent was advanced; however, resistance was encountered.The stent was then implanted in the target lesion.After post dilation, it was noted that the stent migrated distally in the upper part of the svc.The procedure was completed with the implant of a bigger size wallstent to cover and overlap the migrated stent.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr: the device was returned with the stent fully mounted onto the delivery system.Dried blood was visible within the inner lumen of the device indicating that the device was used.During the product analysis the investigator was able to deploy the stent of the device without issue.No issues with the profile of the stent, inner or markerbands of the device.A visual and microscopic examination of the stent found no issue with its profile.The stent outer diameter (od) was measured which is within specification.A visual and tactile examination of the returned device found that the shaft was kinked at various positions along its length.The shaft outer diameter (od) was measured which is within specification.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 migration occurred.Vascular access was obtained via the radial and femoral artery.The totally occluded, 160mm in length, eccentric target lesion was located in the non-tortuous and moderately calcified and 6mm in diameter superior vena cava (svc).A 22 x 70mm x 75cm wallstent-uni endoprosthesis stent was advanced; however, resistance was encountered.The stent was then implanted in the target lesion.After post dilation, it was noted that the stent migrated distally in the upper part of the svc.The procedure was completed with the implant of a bigger size wallstent to cover and overlap the migrated stent.No further patient complications were reported and the patient's status was stable.

• Brand Name: WALLSTENT-UNI? ENDOPROSTHESIS
• Type of Device: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4513562
• MDR Text Key: 5407565
• Report Number: 2134265-2015-00411
• Device Sequence Number: 1
• Product Code: JCT
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K992510
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/18/2016
• Device Model Number: M001731640
• Device Catalogue Number: 73-164
• Device Lot Number: 16748468
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2014
• 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 Outcome(s): Required Intervention
• Patient Age: 45 YR