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

Model Number H7493926228300

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/02/2016

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 calcified coronary artery.A 3.00 x 28 synergy¿ drug-eluting stent was advanced but failed to cross the lesion.When the device was attempted to be removed, the device came into contact with the calcification and the stent became stretched.The procedure was completed with another 3.00 x 28 synergy¿ drug-eluting stent.No patient complications were reported and the patient's status was good.

Manufacturer Narrative

Device evaluated by mfr.: the stent delivery system (sds) was returned for analysis.A visual examination of the crimped stent found distal stent damage with struts from the 11th most proximal row onwards, distorted, lifted from the stent profile and stretched distally on the bumper tip.The outer diameter (od) of the undamaged proximal side of the stent was measured and was within specifications.The balloon cones were reviewed and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.The bumper tip of the device showed no signs of damage.A visual and tactile examination found multiple kinks along the hypotube shaft.This type of damage is consistent with excessive force being applied to the delivery system.A visual and tactile examination of the outer and mid-shaft section found no issues.The inner lumen and 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 most probable root cause is operational context as device performance was limited due to anatomical/procedural factors.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in a calcified coronary artery.A 3.00 x 28 synergy¿ drug-eluting stent was advanced but failed to cross the lesion.When the device was attempted to be removed, the device came into contact with the calcification and the stent became stretched.The procedure was completed with another 3.00 x 28 synergy¿ drug-eluting stent.No patient complications were reported and the patient's status was good.

• 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: 6190709
• MDR Text Key: 62913759
• Report Number: 2134265-2016-11769
• 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,Followup
• Report Date: 12/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2017
• Device Model Number: H7493926228300
• Device Catalogue Number: 39262-2830
• Device Lot Number: 19275429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• 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