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

Model Number H7493926228270

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 04/05/2018

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.Device is a combination product.(b)(4).Device evaluated by mfr.: synergy ous mr 2.75 x 28mm stent delivery system was returned for analysis.An examination of the crimped stent revealed damage.Strut segment 14 from the proximal end of the stent was lifted and pulled in a distal direction.The remainder of the stent was undamaged.The undamaged crimped stent od (outer diameter) was measured and the result was within max crimped stent profile measurement.The balloon cones were reviewed and there were no issues to note.The balloon wings were tightly wrapped and evenly folded.A visual and tactile examination of the hypotube revealed multiple kinks.An examination of the shaft polymer extrusion found no issues.There were no signs of damage or strain to the port bond.The tip was visually examined and no issues were noted.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 damage occurred.A 2.75 x 28 synergy¿ drug-eluting stent was selected for use to treat a lesion.However, during preparation, it was noted that some stent struts were not well crimped on the stent delivery system.The device was never used inside the patient and procedure was completed with another of the same device.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: 7582170
• MDR Text Key: 110473764
• Report Number: 2134265-2018-04889
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2019
• Device Model Number: H7493926228270
• Device Catalogue Number: 39262-2827
• Device Lot Number: 0021718342
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2018
• Initial Date FDA Received: 06/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• 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