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

Model Number H7493927416220

Device Problems Positioning Failure (1158); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2015

Event Type  malfunction  

Event Description

It was reported that balloon rupture occurred.The target lesion was located in the first diagonal artery.A 16mmx2.25mm rebel¿ stent was advanced to the lesion; however, the stent failed to deploy.It was noted that the balloon ruptured.The device was removed from the patient.The procedure was completed with a 2x25x18 non-bsc stent.No patient complications were reported and the patients status was fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of a rebel stent delivery system (sds) with stent.The balloon was tightly folded.The stent was secure between the markerbands.There was blood in the wire lumen.Microscopic examination of the balloon and stent did not reveal any damage or irregularities.Microscopic examination of the shaft revealed a 1cm tear in the inner and outer shaft material at the guidewire exit notch.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 balloon rupture occurred.The target lesion was located in the first diagonal artery.A 16mmx2.25mm rebel stent was advanced to the lesion; however, the stent failed to deploy.It was noted that the balloon ruptured.The device was removed from the patient.The procedure was completed with a 2x25x18 non-bsc stent.No patient complications were reported and the patients status was fine.

• 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: 4714489
• MDR Text Key: 5740657
• Report Number: 2134265-2015-02209
• 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,Followup
• Report Date: 03/26/2015

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: Health Professional
• Device Expiration Date: 07/29/2017
• Device Model Number: H7493927416220
• Device Catalogue Number: 39274-1622
• Device Lot Number: 17161557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/01/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2015
• Initial Date FDA Received: 04/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1