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

Model Number H7493926220400

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/19/2018

Event Type  malfunction  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that stent damage occurred.The 80% stenosed target lesion was located in a severely tortuous and severely calcified vessel.A 4.00 x 20mm synergy¿ stent was advanced to treat the target lesion.However, the device failed to cross the lesion and "eversion" of the stent strut was noted while going into the guidezilla.The procedure was completed with another synergy.There were no patient complications and the patient status was good.

Manufacturer Narrative

Describe event or problem updated.(b)(4).

Event Description

Same case as mdr id: 2134265-2018-05301.It was further reported that a 3.50 x 20 synergy¿ drug-eluting stent was also damaged when used with the same guidezilla.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7611056
• MDR Text Key: 111449058
• Report Number: 2134265-2018-05300
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2019
• Device Model Number: H7493926220400
• Device Catalogue Number: 39262-2040
• Device Lot Number: 21475814
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1