MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493926238250

Device Problems Kinked (1339); Failure to Advance (2524)

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 stent delivery system was returned for analysis broken into two sections and without the manifold.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 the result was within maximum 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 of the hypotube found two hypotube breaks and multiple hypotube kinks.One of the hypotube breaks was within the manifold and strain relief hub which was also broken at this site, the break was 19mm proximal to the distal end the strain relief.The other hypotube break was 20mm distal to the distal end of the strain relief.The manifold and strain relief hub was broken 19mm proximal to the distal end of the strain relief.A visual and tactile examination of the shaft polymer extrusion profile found a mid-shaft kink 47mm proximal to the proximal end of the port bond.A visual and microscopic examination found no damage to the tip profile.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

Same case as mdr id: 2134265-2017-04021.Reportable based on analysis completed on 10 apr2017.It was reported that crossing difficulties were encountered and shaft kink occurred.Vascular access was obtained via the right radial artery.The more than 90% stenosed, de novo target lesion was located in the severely tortuous obtuse marginal (om) artery.After engaging the left main (lm) with a 6 fr.Introducer sheath and crossing the lesion with a non bsc guide wire, serial pre dilatations were performed with a 2.5 x 15mm balloon catheter.A 2.50 x 38 synergy¿ stent was then advanced to treat the lesion but failed to cross and the shaft got kinked upon manipulation.The device was removed from the patient's body and repeat serial dilatations was performed with a 2.5 x 15mm and 2.5 x 20mm balloon catheter and another 2.5 x 38mm promus element¿ plus stent was advanced but still failed to cross even with a non bsc buddy wire support.The physician then decided to put the patient on medical management instead.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed hypotube break.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: 6498143
• MDR Text Key: 72957867
• Report Number: 2134265-2017-03993
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2017

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: 08/01/2017
• Device Model Number: H7493926238250
• Device Catalogue Number: 39262-3825
• Device Lot Number: 18918985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/10/2017
• Initial Date FDA Received: 04/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2016
• 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
• Treatment: EBU - 6 FR GUIDE CATHETER; RUNTHROUGH AND BMW GUIDE WIRE
• Patient Age: 69 YR