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

Model Number UNK776

Device Problem Peeled/Delaminated (1454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Fujimoto, yoshihie, et.Al., 'delamination of novel ultrathin bioabsorbable abluminal polymer of platinum chromium everolimus-eluting stent', cardioasc interv and ther 2018 33:97-98, https://doi.Org/10.1007/s12928-016-0442-9.Device is a combination product.(b)(6).(b)(4).Device evaluated by mfr: the complaint device was not received for analysis.The investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).

Event Description

It was reported via literature that polymer delamination occurred.The 90% stenosed target lesion was located in the severely calcified mid-left anterior descending coronary artery (lad).After predilatation, delivery of a 24mm synergy stent in the mid-lad was attempted.However, it would not advance to the target lesion in the mid-lad even with the a non-bsc guide extension catheter.Rotational atherectomy was performed.A durable polymer everolimus-eluting stent was then deployed.The final angiogram showed a good result.Scanning electron microscopy demonstrated damage to the bioabsorbable polymer of the synergy stent; most of the damage was delamination of abluminal polymer.It was concluded that delamination of abluminal bioabsorbable polymer may occur more easily and severely when it is delivered through a calcified coronary artery.

• 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: 7587876
• MDR Text Key: 110707227
• Report Number: 2134265-2018-05126
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 76 YR