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

Model Number H7493926220400

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

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: 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 target lesion was located in the moderately tortuous right coronary artery.A 4.00 x 20mm synergy¿ drug-eluting stent was advance to treat the lesion.However, the device failed to cross and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications nor injuries were reported.

Manufacturer Narrative

Device avail.For eval, returned to mfr.On, device returned to mfr., device evaluated by mfr., eval summary, method codes, result codes and conclusion codes updated.Device evaluated by mfr: a synergy ous mr 4.00 x 20mm stent delivery system was returned for analysis.The stent was damaged and moved in a proximal direction exposing the distal balloon wall for a length of 5mm.The manufacturing crimp data for this device was reviewed and there were no anomalies noted.The maximum stent profile was measured and is within the specification.The balloon had not been subjected to any significant positive pressure.There were crimp markings evident on the exposed balloon wall.A visual and tactile examination of the hypotube revealed no issues.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 damage was 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 operational context as the product meets the design and manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported that stent damage occurred.The target lesion was located in the moderately tortuous right coronary artery.A 4.00 x 20mm synergy¿ drug-eluting stent was advance to treat the lesion.However, the device failed to cross and it was noted that the stent struts were lifted.The procedure was completed with another of the same device.No patient complications nor injuries were reported.

• Brand Name: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7614334
• MDR Text Key: 111548537
• Report Number: 2134265-2018-05668
• 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
• Type of Report: Initial,Followup
• Report Date: 06/06/2018

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: 01/02/2019
• Device Model Number: H7493926220400
• Device Catalogue Number: 39262-2040
• Device Lot Number: 0020877898
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2018
• Initial Date Manufacturer Received: 06/06/2018
• Initial Date FDA Received: 06/19/2018
• Supplement Dates Manufacturer Received: 07/24/2018
• Supplement Dates FDA Received: 08/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1