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

Lot Number 0022057114

Device Problem Obstruction of Flow (2423)

Patient Problems Chest Pain (1776); Fatigue (1849); Reocclusion (1985)

Event Date 07/26/2019

Event Type  Injury  

Manufacturer Narrative

Device is a combination product.

Event Description

(b)(6) clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2018, clinical status assessment indicated tha the subject's qualifying condition was stable angina and the index procedure was performed on the same day.The target lesion was located on the 1st obtuse marginal with 90% stenosis and was 38 mm long with a reference vessel diameter of 2.7 mm.The target lesion was treated with pre-dilatation and placement of a 2.50 x 48 mm study stent.Following post-dilatation, residual stenosis was 0%.One day post procedure, the subject was discharged with on dual antiplatelet therapy.In (b)(6) 2019, the subject presented to the emergency department with complaints of worsening chest pain on exertion and fatigue for past several months.It was found out that post stent implantation back in (b)(6) 2018, the subject was in good condition for about 3 months; after that, pain became persistent and worsens with walking on treadmill.The subject was not on any nitro usage and denied any shortness of breath, orthopnea, paroxysmal nocturnal dyspnea (pnd), palpitations and syncope.At the time of reporting, the subject was on aspirin and clopidogrel.The subject did not reveal any acute changes as compared to electrocardiogram (ekg) in 2018.In (b)(6) 2019, coronary angiography was performed which revealed 80% proximal stenosis and 80% distal stenosis in the 1st marginal, and 80% stenosis in 2nd marginal, supplied by vein graft.On the same day, two discrete lesions in the proximal and distal part of in 1st marginal were treated with 3.0x12mm and 2.5x12mm non-bsc stents with 0% residual stenosis.Post procedure, no further complications were noted.The patient was discharged on dual antiplatelet therapy.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9575876
• MDR Text Key: 175029586
• Report Number: 2134265-2019-16467
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 01/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/18/2019
• Device Lot Number: 0022057114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2018
• 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 Age: 58 YR