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

Model Number H7493926238300

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: stent delivery system was returned for analysis.A visual examination of the stent found that from mid-section and towards the distal end of the stent was damaged with struts stretched in a distal direction.No visible damage was noted at the proximal section of the stent.The undamaged proximal section of the crimped stent outer diameter was measured and the result was within the maximum crimped stent profile measurement.Stent damage most likely occurred due to handling during preparation.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded on the distal balloon cones and were not subjected to positive pressure.A visual examination of the bumper tip showed no signs of damage.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 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 16-apr-2018.It was reported that stent was defective.A 3.00x38mm synergy¿ drug-eluting stent was selected for use.However, it was noted that stent had defect.However, returned device analysis revealed stent damage.

• 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: 7503260
• MDR Text Key: 107981054
• Report Number: 2134265-2018-03827
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 04/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/03/2017
• Device Model Number: H7493926238300
• Device Catalogue Number: 39262-3830
• Device Lot Number: 0018793433
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/21/2016
• 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