MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Device Problem Obstruction of Flow (2423)

Patient Problem Reocclusion (1985)

Event Date 08/21/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

It was reported that in-stent restenosis occurred.On an unspecified date, a synergy ii stent was implanted in the distal left anterior descending artery (lad).In (b)(6) 2019, the 90% in-stent restenosed target lesion was located in the mildly tortuous and mildly calcified distal lad.Following predilitation with a 2.0x15mm non-bsc balloon, a 2.5 x 24 synergy des was advanced but failed to cross the implanted stent.A 2.5 x 16 synergy des was advanced but it also failed to cross and the stent dislodged from the delivery balloon.The dislodged stent was removed with a snare and the procedure was completed with another 2.5 x 16 synergy stent.No further complications were reported.

• Brand Name: SYNERGY
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9012460
• MDR Text Key: 159686908
• Report Number: 2134265-2019-11081
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2019
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention
• Patient Age: 74 YR