MAUDE Adverse Event Report: ABBOTT VASCULAR RX XIENCE XPEDITION; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1070300-28

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

Patient Problems Angina (1710); Stenosis (2263)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

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 stenosis and angina are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary 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.

Event Description

(b)(6).It was reported that on (b)(6) 2014, the patient was hospitalized for intermittent chest pain for 4 months, aggravating for half a month.Coronary angiography was performed on (b)(6) 2014, and a 3.0x28 mm xience xpedition stent was implanted in obtuse marginal (om) coronary artery and the 3.5x15 mm xience xpedition stent was successfully implanted in the middle of the left circumflex (lcx) artery with 99% stenosis.The patient was discharged on (b)(6) 2014.Information received from the 5 year follow up indicated that on (b)(6) 2019, the subject was re-hospitalized for discomfort in the anterior cardiac region while tired or having a cold.Coronary angiography was performed on (b)(6) 2019, which showed 80% stenosis in the proximal of left anterior descending (lad) coronary artery.The stent in the proximal of lcx was unobstructed.There was a 70% stenosis in the proximal of om1, 60% stenosis in the proximal, middle and distal of rca.A 3.5 x 38 mm non-abbott stent was implanted.The subject was discharged from hospital on 04/15/2019 after improvement.The physician stated that the event was not related to the device.No additional information was provided.

• Brand Name: RX XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 10568436
• MDR Text Key: 213447537
• Report Number: 2024168-2020-07902
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: CH
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/22/2020

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: 11/12/2015
• Device Catalogue Number: 1070300-28
• Device Lot Number: 3110442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR
• Patient Weight: 75