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

Model Number UNK776

Device Problem Bent (1059)

Patient Problems Death (1802); Perforation of Vessels (2135); Cardiogenic Shock (2262)

Event Date 11/28/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

Same case as mfr report#: 2134265-2017-12991.It was reported that stent damage and vessel perforation occurred and the patient expired.The 90% stenosed, 3.0mm in diameter target lesion was located in the highly calcified right coronary artery (rca).The target lesion was treated with pre-dilation and placement of a 3.0x32mm synergy ii drug eluting stent.Following post-dilation with a 3.0mm nc emerge balloon catheter, a perforation was noticed, which was covered with a non-bsc stent.The rca was recovered.Upon further investigation, it was noticed that there was a stent fracture, which was most likely caused by the balloon inflations.The stent remained in one piece but it appeared that the struts were pushed out of alignment.Another 70% stenosed target lesion was located in the heavily calcified and moderately sized left anterior descending artery (lad).The patient was coded in the lab and the lad was opened with plain old balloon angioplasty.Hours later the patient expired.The cause of death was probably cardiogenic shock.No autopsy was performed.

• 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: 7137940
• MDR Text Key: 95488166
• Report Number: 2134265-2017-12990
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 11/30/2017
• Initial Date FDA Received: 12/21/2017
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR