MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE EPIC? VASCULAR; STENT, ILIAC

Model Number H74939200061220

Device Problems Bent (1059); Difficult to Remove (1528); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/31/2014

Event Type  Injury  

Event Description

It was reported that catheter removal difficulty and stent damage occurred.The patient presented with rest pain.The target lesion was located in the mid superficial femoral artery (sfa).After a 0.014 platinum plus guide wire crossed the lesion, a 6x120x120 epic¿ vascular stent was advanced and successfully deployed.While trying to remove stent delivery system (sds), the sds was snagged on the stent strut of the recently implanted stent at approximately 30mm from the distal segment of the stent.The sds cannot be moved forward or backwards.It was then noted that the stent was bunched up.The physician attempted to re-sheath the sds but failed.An unspecified introducer sheath was used to disengage the brake to re-sheath the sds and was able to remove it.The stent was post dilated using an unspecified balloon catheter and the procedure was completed successfully.No patient complications were reported and the patient's status was stable.

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).

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an epic stent delivery system (sds) with no other devices.There was blood on the handle.There was no damage or irregularities to the handle and outer sheath.There were numerous kinks throughout the inner shaft.The stent was not returned for analysis as it was implanted.There was no evidence of any material or manufacturing deficiencies contributing to the withdrawal difficulty and the identified kinks.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 catheter removal difficulty and stent damage occurred.The patient presented with rest pain.The target lesion was located in the mid superficial femoral artery (sfa).After a 0.014 platinum plus guide wire crossed the lesion, a 6x120x120 epic¿ vascular stent was advanced and successfully deployed.While trying to remove stent delivery system (sds), the sds was snagged on the stent strut of the recently implanted stent at approximately 30mm from the distal segment of the stent.The sds cannot be moved forward or backwards.It was then noted that the stent was bunched up.The physician attempted to re-sheath the sds but failed.An unspecified introducer sheath was used to disengage the brake to re-sheath the sds and was able to remove it.The stent was post dilated using an unspecified balloon catheter and the procedure was completed successfully.No patient complications were reported and the patient's status was stable.

• Brand Name: EPIC? VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4273704
• MDR Text Key: 18871458
• Report Number: 2134265-2014-07167
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/03/2014

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: 09/16/2017
• Device Model Number: H74939200061220
• Device Catalogue Number: 39200-06122
• Device Lot Number: 0017290164
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2015
• Initial Date FDA Received: 11/24/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: 0.014 PLATINUM PLUS
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR