MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

Model Number 10622

Device Problems Break (1069); Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problems Chest Pain (1776); Dyspnea (1816); Edema (1820); Pulmonary Edema (2020); Tachycardia (2095); Thrombosis (2100)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

It was reported that removal difficulty, shaft break, and acute thrombosis occurred. Vascular access was obtained via the femoral artery. The 70% stenosed, 38mmx3. 5mm target lesion was located in a non-tortuous, mildly calcified right coronary artery. Pre-procedure, the patient was given 300mg aspirin and 300mg clopidogrel. Intra-procedure, the patient was given tirofiban. Following pre-dilatation with a 3. 0x20mm non-bsc balloon, the stenosis remained at 50%. A total of four stents were implanted in the right coronary artery, including a 4. 0x20mm synergy, 3. 5x32mm synergy (complaint in question), 3. 5x32mm synergy and a 3. 5x38mm non-bsc stent. Post implant of the first 3. 5 x 32mm synergy ii des stent, the balloon catheter was difficult to remove from the stent and also became stuck in the guiding catheter. The shaft of the balloon was also noted to be detached/separated. Both the guiding catheter and stent balloon catheter were safely removed from the patient. A new guiding catheter was used and the procedure was successfully completed. Post procedure, the patient developed chest pain associated with dyspnea. Electrocardiography was performed immediately which revealed sinus tachycardia and subtle changes of high side wall. It appeared ventilator failure was imminent so the patient was immediately returned to the cath lab with suspected acute stent thrombosis. There was appreciated thrombotic load, not occlusive. No stent deformation was noted. Further intervention was performed with intracoronary tirofiban and the patient is reported to be stable.

• Brand Name: SYNERGY
• Type of Device: CORONARY DRUG-ELUTING STENT
• 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: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8362582
• MDR Text Key: 136893578
• Report Number: 2134265-2019-01610
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (Y/N): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 04/10/2019

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 02/22/2019
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 12/22/2019
• Device MODEL Number: 10622
• Device Catalogue Number: 10622
• Device LOT Number: 22327756
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/07/2019
• Is The Reporter A Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated By Manufacturer?: Yes
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient TREATMENT DATA

Date Received: 02/22/2019 Patient Sequence Number: 1