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

Model Number H7493926238220

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that the stent moved on the balloon.The 82% stenosed target lesion was located in the moderately tortuous and mildly calcified left circumflex artery to the obtuse marginal branch.After a 2.0x15mm maverick balloon catheter was advanced for dilation, a 2.25 x 38mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion.It was noted that the stent strut was caught on calcium causing the stent to moved on the balloon.The procedure was completed with a 2.25x38mm non-bsc stent.No further patient complications were reported and the patient's status was stable.

Manufacturer Narrative

  device evaluated by mfr: synergy ous, mr, 2.25x38mm, stent delivery system was returned for analysis.A visual examination of the crimped stent found the distal portion of the stent was damaged and stretched distally out over the distal tip.The struts on the proximal end of the stent were intact and in a crimped state on the balloon.The stent did not move on balloon.It is likely the crimped stent may have encountered resistance & subsequent damage during the attempt to withdraw the device.The undamaged proximal stent od (outer diameter) measured within the maximum crimped stent specification indicating that there were no issues with the crimp stent profile.A visual examination of the balloon cones was performed 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 no issue with the hypotube.A visual and tactile examination found no issue with the extrusion.The bi-component bond showed no signs of damage or strain.A visual and tactile examination found no damage to the tip.No other issues noted during analysis.The investigation conclusion is operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that the stent moved on the balloon.The 82% stenosed target lesion was located in the moderately tortuous and mildly calcified left circumflex artery to the obtuse marginal branch.After a 2.0x15mm maverick balloon catheter was advanced for dilation, a 2.25 x 38mm synergy drug-eluting stent was advanced but failed to cross the lesion.It was noted that the stent strut was caught on calcium causing the stent to moved on the balloon.The procedure was completed with a 2.25x38mm non-bsc stent.No further 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: 7139527
• MDR Text Key: 95800960
• Report Number: 2134265-2017-12677
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KR
• 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: 12/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2018
• Device Model Number: H7493926238220
• Device Catalogue Number: 39262-3822
• Device Lot Number: 0020487785
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2017
• 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
• Patient Age: 83 YR