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

Model Number H7493926228270

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/07/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years old or older.Device is combination product.(b)(4).

Event Description

It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.75 x 28mm synergy¿ drug-eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion and it was noted that the stent struts were lifted.The procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: the synergy ous mr 2.75 x 28 mm stent delivery system was returned for analysis.A visual examination of the stent found no issues on 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 markerbands.The crimped stent outer diameter was measured and 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.The tip was visually and microscopically examined and signs of damage were noted at the distal edges of the tip.This type of damage most likely occurred when the tip was pushed against a restriction.A visual and tactile examination found no kinks or damage along the hypotube shaft.A visual and tactile examination of the outer and the inner lumen and mid-shaft section found no issues with the extrusion shaft.The bi-component bond showed no signs of damage or strain.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 investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that stent damage occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified left circumflex artery.A 2.75 x 28mm synergy drug-eluting stent was advanced to treat the lesion.However, the device failed to cross the lesion and it was noted that the stent struts were lifted.The procedure was completed with a non-bsc stent.No patient complications were reported and the patient's status was stable.

• 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: 7634543
• MDR Text Key: 112300083
• Report Number: 2134265-2018-05923
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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,Followup
• Report Date: 06/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/11/2018
• Device Model Number: H7493926228270
• Device Catalogue Number: 39262-2827
• Device Lot Number: 20094820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2017
• 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