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

Catalog Number 1070300-48

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

Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838); Ischemia (1942); Myocardial Infarction (1969)

Event Date 03/19/2020

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 angina and ischemia are listed in the xience xpedition 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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Patient id: (b)(6) it was reported that on (b)(6) 2020 two xience xpedition stents, both 3.0x48 mm sizes, were implanted in the mid right coronary artery.On (b)(6) 2020 the patient had angina and was admitted to the hospital.There was no change to the electrocardiogram.The troponin levels on (b)(6) 2020 were elevated and were decreasing during the hospitalization.A myocardial perfusion scan possibly indicated the presence of inferior ischemia.Medication was administered, a minitran patch.The condition resolved on (b)(6) 2020.No additional information was provided.

Manufacturer Narrative

The reported patient effect of myocardial infarction is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.He reported patient effect of myocardial infarction is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.H6: patient code 1838 was removed.Conclusion code 67 was removed.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2020 two xience xpedition stents, both 3.0x48 mm sizes, were implanted in the mid right coronary artery.On (b)(6) 2020 the patient had angina and was admitted to the hospital.There was no change to the electrocardiogram.The troponin levels on (b)(6) 2020 were elevated and were decreasing during the hospitalization.A myocardial perfusion scan possibly indicated the presence of inferior ischemia.Medication was administered, a minitran patch.The condition resolved on (b)(6) 2020.Subsequent to the previously filed report, additional information was received that on (b)(6) 2020 the patient had a new myocardial infarction after the stent procedure.No additional information was provided.

• Brand Name: XIENCE XPEDITION
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9979426
• MDR Text Key: 189741069
• Report Number: 2024168-2020-03771
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 09/02/2020

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: 07/30/2022
• Device Catalogue Number: 1070300-48
• Device Lot Number: 9072241
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/03/2020
• Initial Date FDA Received: 04/20/2020
• Supplement Dates Manufacturer Received: 08/10/2020
• Supplement Dates FDA Received: 09/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XIENCE XPEDITION 3.0X48
• Patient Outcome(s): Hospitalization; Required Intervention; Disability
• Patient Age: 75 YR
• Patient Weight: 85