MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1550225-18

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

Patient Problems Ischemia (1942); Thrombosis (2100); Ventricular Tachycardia (2132)

Event Date 02/22/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for evaluation.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 ischemia and thrombosis are listed in the xience sierra, everolimus eluting coronary stent systems instructions for use, as a 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.The 2.5x28mm (8102441) and 2.25x12mm xience sierra (8090341) stents referenced are filed under separate medwatch reports.

Event Description

It was reported that on (b)(6) 2019, the patient was admitted with st elevation myocardial infarction, thrombus and cardiac arrest.A 2.25 x 18 mm xience sierra stent (8120341) and a 2.5 x 28 mm xience sierra stent (8102441) were implanted in the proximal left anterior descending (lad) artery.Sluggish flow was noted after stent deployment; however, no additional intervention was performed.On (b)(6) 2019, the patient experienced ventricular tachycardia and was taken back to the cath lab.Coronary angiography noted thrombus in the stented segment.A 2.5 x 33 mm xience sierra stent and a 2.25 x 12 mm xience sierra stent (8090341) were implanted to treat the thrombus.Post dilatation was performed using an unspecified nc dilatation catheter.A non-flow limiting edge dissection was noted at the 2.25 x 12 mm xience sierra stent.No additional intervention was performed to treat the dissection.Post procedure, the patient was in stable condition.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8561588
• MDR Text Key: 143444486
• Report Number: 2024168-2019-03378
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227028
• UDI-Public: 08717648227028
• 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: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/07/2019
• Device Catalogue Number: 1550225-18
• Device Lot Number: 8120341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2018
• 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
• Treatment: 2.5X28MM XIENCE SIERRA (8102441)
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR