MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Model Number 1550300-38

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

Patient Problems Angina (1710); Bradycardia (1751); Cardiac Arrest (1762); Death (1802); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Pericardial Effusion (3271)

Event Date 11/17/2020

Event Type  Death  

Manufacturer Narrative

The device was not returned for evaluation as the stent remains in the patient. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. The reported patient effects of perforation, angina, death, pericardial effusion and hypotension are listed in the xience sierra everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined. However, the treatment appears to be related to the operational context of the procedure. There is no indication of a product quality issue with respect to manufacture, design or labeling. The graftmaster device referenced is being filed under a separate medwatch report number.

Event Description

This is filed on the first xience stent deployed. It was reported that the xience 3. 0x38 was deployed first in the mid right coronary artery (rca) and overlapped the 4. 0x18 xience that was implanted in the proximal rca second. A 4. 0 nc (non-compliant) bdc (balloon dilatation catheter) was used to post dilate and then a 4. 0x15 nc bdc at 18 atmospheres. Patient then had chest pain and a perforation in the mid rca was noted, likely from post dilatation. The 3. 5x19 mm graftmaster stent was inserted to treat the perforation, but it was unable to cross through the stents due to the tortuosity. The patient went into cardiac arrest as she became hypotensive and bradycardic. Cardiopulmonary resuscitation (cpr) was performed with administration of epinephrine, atropine, bicarbonate. Transthoracic echocardiogram showed a large pericardial effusion. Pericardiocentesis drained 1. 1 liters of blood. The graftmaster was attempted again with another guide wire, but it was still unable to cross. Cpr was discontinued after a long time of performing it and in view of unlikely recovery. The patient expired. No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005718570 (P099); cashel road; clonmel tipperary ; EI
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10977841
• MDR Text Key: 220508735
• Report Number: 2024168-2020-10336
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 01/05/2022
• Device Model Number: 1550300-38
• Device Catalogue Number: 1550300-38
• Device Lot Number: 0062441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 12/09/2020 Patient Sequence Number: 1

Treatment

4.0X18 MM XIENCE SIERRA STENT