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

Catalog Number 1550300-15

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Dyspnea (1816); Myocardial Infarction (1969); Dyskinesia (2363)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number e2019001. The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no similar incidents from this lot. The reported patient effect of myocardial infarction is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. The investigation was unable to determine a conclusive cause for the reported patient-device incompatibility (wall apposition); however, factors that may contribute to patient-device incompatibility (wall apposition) include, but are not limited to, incorrect device size for lesion, patient anatomical morphology, and patient disease state, and insufficient post-dilation. The reported patient effects and treatment appear to be related to operational context of the procedure as it is likely the under deployed stent caused the reported myocardial infarction, dyspnea, dyskinesia, clamminess, additional therapy/non-surgical treatment and hospitalization. There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Study patient (b)(6). It was reported that the procedure was performed on (b)(6) 2019, treating a target lesion in the mid left anterior descending (lad) artery. The 3. 0 x 15 mm xience sierra stent was implanted without issue. On (b)(6) 2019, the patient was working at home and developed difficulty breathing and shivering, with clamminess. Emergency medical services was called and administered aspirin. The patient was transported to the emergency department and hospitalized. The patient was hemodynamically stable. Troponin levels were elevated and non-st elevation myocardial infarction was diagnosed. The patient was taken to the cath lab and coronary angiography noted that the stent was underdeployed. Balloon angioplasty was performed. Antiplatelet medications were administered. The patient was observed for two days. The event resolved on 11/16/2019 and the patient was discharged to home. There was no additional information provided.

• Brand Name: XIENCE SIERRA
• 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: 9454870
• MDR Text Key: 173713399
• Report Number: 2024168-2019-14416
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,study

Reporter Occupation

• Type of Report: Initial
• Report Date: 12/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/12/2019
• Device Catalogue Number: 1550300-15
• Device Lot Number: 8090541
• 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: 11/18/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/13/2018
• 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: 12/11/2019 Patient Sequence Number: 1