MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE REBEL; STENT, CORONARY

Model Number H7493927420270

Device Problems Stretched (1601); Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2015

Event Type  Injury  

Event Description

It was reported that inadequate stent apposition, elongation and explantation of stent occurred.The target lesion was located in the internal carotid artery.A 20 x 2.75mm rebel stent was advanced and deployed in the lesion.The stent delivery system (sds) balloon was deflated and the sds was removed however it was noted that the stent appeared elongated and was unraveled to the sds.The stent was removed using a non bsc snare and the procedure was completed by implantation of a 3.5x24mm rebel stent.No patient complications were reported.

Manufacturer Narrative

(b)(4).Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause has been determined to be use/user error as the device was attempted to be placed in the internal carotid artery and the dfu states: "the rebel coronary stent system is indicated for improving coronary luminal diameter in patients with de novo lesions = 28 mm in length in native coronary arteries with a reference vessel diameter (rvd) of = 2.25 mm to = 4.50 mm." (b)(4).

• Brand Name: REBEL
• Type of Device: STENT, CORONARY
• 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: 4900236
• MDR Text Key: 6829736
• Report Number: 2134265-2015-04365
• Device Sequence Number: 1
• Product Code: MAF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• 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
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2017
• Device Model Number: H7493927420270
• Device Catalogue Number: 39274-2027
• Device Lot Number: 17078966
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2014
• 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