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

Model Number H7493926216400

Device Problems Bent (1059); Device Damaged by Another Device (2915)

Patient Problem Failure of Implant (1924)

Event Date 03/20/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in a coronary artery.Following pre-dilatation, a 4.00 x 16 synergy¿ drug-eluting stent was advanced to treat the lesion.However, while the device was engaging inside the guide catheter, the distal part of the stent came into contact with the proximal part of the guide catheter, causing the stent to crumble.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr: stent delivery system was returned for analysis with a section of guide catheter.A visual examination found that the stent was returned detached from the sds and stuck in a section of guide catheter that had been cut.The stent was removed from the guide catheter using tweezers.The stent was severely damaged and stretched its entire length.The maximum crimped stent profile measurement at the time of manufacture was within specification.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and do not appear to have been subjected to positive pressure.Stent crimp markings were present on the balloon body indicating the stent was crimped to the balloon prior to shipping.A visual and microscopic examination of the bumper tip showed no signs of damage.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the outer and inner lumen and mid-shaft section found no issues along the shaft 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 caused by other device as another device/drug/subsequent procedure caused the complaint event.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in a coronary artery.Following pre-dilatation, a 4.00 x 16 synergy drug-eluting stent was advanced to treat the lesion.However, while the device was engaging inside the guide catheter, the distal part of the stent came into contact with the proximal part of the guide catheter, causing the stent to crumble.The 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: 7410313
• MDR Text Key: 105128128
• Report Number: 2134265-2018-02941
• 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: 03/20/2018

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: 03/18/2019
• Device Model Number: H7493926216400
• Device Catalogue Number: 39262-1640
• Device Lot Number: 21166398
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/09/2018
• Supplement Dates Manufacturer Received: 04/17/2018
• Supplement Dates FDA Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2017
• 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