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

Model Number H7493926220400

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

Age at time of event : 18 years or older.Device is a combination product.(b)(4).Stent delivery system was returned for analysis.A visual examination found that the stent was pulled in a distal direction on the balloon with some struts pulled over the distal tip.The stent struts were stretched and misaligned.There was minimal damage to the proximal stent struts.The maximum crimped stent profile measurement was within specification.A stent protector was returned with the device.The stent protector id (inner diameter) measured and was within specification.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and in their original folded position and did not appear to have been subjected to positive pressure.Stent crimp markings were present on the balloon body.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found multiple kinks along the full length of the catheter.A visual and tactile examination of the outer and the inner lumen and midshaft section found no issues along the polymer extrusion.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

It was reported that stent dislodgement occurred.During preparation of a 4.00x20mm synergy¿ stent, it was noted that the stent was removed together with the stent protector.The procedure was completed with another of the same device.No patient complications were reported.

• 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: 7104354
• MDR Text Key: 95056892
• Report Number: 2134265-2017-11915
• 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
• Report Date: 11/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2018
• Device Model Number: H7493926220400
• Device Catalogue Number: 39262-2040
• Device Lot Number: 0019749948
• 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: 11/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2016
• 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