MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926024250

Device Problems Break (1069); Kinked (1339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.  (b)(4).Device evaluated by mfr.: a synergy ii us mr 2.50 x 24mm stent delivery system (sds) was returned for analysis broken into 2 sections.A visual and microscopic examination of the crimped stent found no issues with the stent.There were no signs of damage, stretching or lifting of the stent struts.The stent showed no signs of movement and was set equidistant between the proximal and distal marker bands.The crimped stent od(outer diameter) was measured and is within max crimped stent profile measurement.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and tactile examination found a hypotube break and multiple hypotube kinks.The hypotube was broken 217mm distal to the distal end of the strain relief.A visual and tactile examination of the shaft polymer extrusion found no issues.The bi-component bond showed no signs of damage or strain.A visual and microscopic examination found no issues with 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 has been determined to be use/user error as the event states that upon noticing a hypotube kink, rather than ceasing use of the catheter the physician made an attempt to straighten out the kink in the hypotube, resulting in a break.Direction for use states ¿at any time during use of the monorail¿ stent delivery system, if the proximal shaft (hypotube) has been bent or kinked, do not continue to use the catheter.¿ (b)(4).

Event Description

Reportable based on device analysis completed on 14-mar-2017.It was reported that shaft break occurred in a segment that cannot enter the patient's body.The target lesion was located in the coronary artery.A 2.50 x 24 synergy ii everolimus-eluting platinum chromium coronary stent system was advanced to treat the lesion.However, the shaft got kinked a little bit and the physician tried to straighten it out and it broke less than 15cm from the hub.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was fine.However, returned device analysis revealed hypotube broke at a point that could potentially enter the patient.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6459054
• MDR Text Key: 71719211
• Report Number: 2134265-2017-02693
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840213
• UDI-Public: (01)08714729840213(17)20170708(10)19488549
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2017

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: 07/08/2017
• Device Model Number: H7493926024250
• Device Catalogue Number: 39260-2425
• Device Lot Number: 19488549
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2016
• 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