MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS PREMIER¿; STENT, CORONARY, DRUG-ELUTING

Model Number H7493952824350

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

Patient Problems Intimal Dissection (1333); Ventricular Tachycardia (2132)

Event Date 06/07/2015

Event Type  Injury  

Event Description

(b)(4).It was reported that vessel dissection occurred.In (b)(6) 2015, the patient presented with an anterior wall st elevation myocardial infarction (stemi) and underwent an emergent percutaneous coronary intervention (pci).There were 2 target lesions and no non-target lesions.Target lesion #1 was a de novo lesion located in the proximal right coronary artery (rca) with 95% stenosis.It was 20mm long, with a reference vessel diameter of 3.5mm with mild calcification.It was the culprit lesion for the stemi.The lesion was not predilated and a 3.50 x 28mm promus premier¿ stent was implanted resulting to 0% residual stenosis.Post dilation was performed and the patient¿s pain was resolved with improved ecg reading.Target lesion #2 was a de novo lesion located in the second obtuse marginal (om) with 95% stenosis.It was 20mm long, with a reference vessel diameter of 3.5mm with moderate calcification and moderate vessel tortuosity.Target lesion #2 was treated with predilation using a 3.0mm in diameter balloon catheter at 14 atmospheres.Then a 3.50x24mm promus premier¿ stent was advanced but could not be delivered due to the degree of calcification and tortuosity of the lesion.Use of a buddy wire and a non bsc guide extension catheter were also unsuccessful.The physician switched to a non bsc catheter and easily rewired the vessel.Then with some difficulty, the stent was delivered and was deployed at nominal pressure with good results.During insertion of the stent, there appeared to be either a small edge grade a dissection or a pseudo-stenosis from the wire proximal to the stent.The most severe dissection was located proximal to the target lesion, which required an implantation of a 3.50 x 12mm promus premier¿ stent in an overlapping manner.Post dilation was performed using a 3.5mm in diameter balloon catheter at 11 atmospheres.Post insertion of the two stents, the residual stenosis was 0% with a timi 3 flow.Angiographic results were excellent and the patient was pain-free.The event was considered to be resolved on the same day.One day post procedure, there was an asymptomatic, non-sustained 15 beat wide-complex tachycardia, consistent with non-sustained ventricular tachycardia, which was treated with oral potassium.Subsequently, frequent premature ventricular contractions (pvcs) were noted, but no further episodes of ventricular tachycardia occurred.Two days post procedure, the patient was discharged on aspirin and brilinta (ticagrelor).

Manufacturer Narrative

(b)(4).Device is a combination product.Device evaluated by mfr: the complaint device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the physician attributed the non- sustained ventricular tachycardia and premature ventricular contractions to myocardial infarction upon admission and low potassium.The patient was not placed on an anti-arrhythmic agent.There was no relationship of these events to the implantation of the 3.50 x 28mm and the 3.50x24mm promus premier¿ stents.

• Brand Name: PROMUS PREMIER¿
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4920056
• MDR Text Key: 6011616
• Report Number: 2134265-2015-04466
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/17/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/05/2016
• Device Model Number: H7493952824350
• Device Catalogue Number: 39528-2435
• Device Lot Number: 17601562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/17/2015
• Initial Date FDA Received: 07/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2015
• 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: 65 YR