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

Model Number H7493926216300

Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/30/2017

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.  (b)(4).Device evaluated by mfr: a synergy ous mr 3.00 x 16 mm stent delivery catheter (sdc) was returned for analysis without a stent.There was no stent on the balloon.The balloon was reviewed and no damage was noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.Stent crimp markings were evident on the balloon indicating correct positioning and crimping of the stent prior to the complaint incident.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of shaft polymer extrusion found no issues.A visual and microscopic examination of the tip found damage to the tip.No other issues were identified during the product analysis.The manufacturing crimp data for this device was reviewed and the crimping process & controls did not highlight any anomalies.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.  (b)(4).

Event Description

Reportable based on device analysis completed on 01-dec-2017.It was reported that crossing difficulties were encountered.The 85% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery (rca).After predilation was performed, a 3.00 x 16mm synergy¿ drug-eluting stent was advanced but failed to cross the lesion.The procedure was completed with another synergy stent.No patient complications were reported and the patient's status was stable.However, returned device analysis revealed stent detachment.It was further reported that after removal of the device from the patient's body, it was separated from the delivery system while the physician was checking the stent status.

• 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: 7138584
• MDR Text Key: 95611764
• Report Number: 2134265-2017-12409
• 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
• Report Date: 12/01/2017

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: 01/02/2019
• Device Model Number: H7493926216300
• Device Catalogue Number: 39262-1630
• Device Lot Number: 20883983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2017
• 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: 55 YR