MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926012270

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Perforation of Vessels (2135); No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  Injury  

Manufacturer Narrative

Complainant name: (b)(6) medical center.Device is a combination product.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

(b)(4) clinical study.It was reported that vessel perforation occurred.In (b)(6) 2017, patient's clinical status assessment indicated the patient's qualifying condition as stable angina and silent ischemia.The patient was referred for cardiac catheterization and index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) with 80% stenosis and was 25.0mm long with a reference vessel diameter of 3.00mm.The lesion was treated with direct placement of a 3.00x28mm study stent.Following post dilatation, residual stenosis was 0%.Target lesion #2 was located in the distal left circumflex artery (lcx) with 80% stenosis and was 70mm long with a reference vessel diameter of 2.75mm.The lesion was treated with direct placement of a 2.75x12mm synergy ii stent, however, following stent deployment vessel perforation was noted.Following post dilatation, residual stenosis was 0%.On the same day, the patient was discharged on dual antiplatelet therapy.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that no vessel perforation occurred.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 7204612
• MDR Text Key: 97711559
• Report Number: 2134265-2017-13336
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840046
• UDI-Public: 08714729840046
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• 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,Followup
• Report Date: 12/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/23/2018
• Device Model Number: H7493926012270
• Device Catalogue Number: 39260-1227
• Device Lot Number: 20705090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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): Other
• Patient Age: 83 YR