MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

Catalog Number 1017300-48

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

Patient Problems Heart Failure (2206); Pseudoaneurysm (2605)

Event Date 10/27/2020

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 effect of pseudoaneurysm is listed in the xience xpedition 48 everolimus eluting coronary stent systems instructions for use as a known patient effect 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.The xience pro 48 device is not commercially available in the u.S.; however, it is similar to a device that is sold in the u.S.

Event Description

Patient id: (b)(6).It was reported that on (b)(6) 2019 two xience pro 48 stents (sizes 3.0x48 and 3.5x48 mm) were implanted in the proximal left anterior descending coronary artery.On 10/27/2020 the patient was hospitalized for an episode of acute heart failure.The patient underwent a coronary angiography which showed patency of the stents previously implanted in the anterior descendant (target vessel of the study).Angiography also highlighted the presence of a pseudo-aneurysm at the site of the previous coronary rupture.The diagnosis was confirmed with a new oct (optical coherence tomography) study and it was decided to proceed with stenting the pseudo-aneurysmal tract by placing a covered stent.The covered stent was placed in the 3.0x48 study stent to prevent a vessel rupture.No additional information was provided.

• Brand Name: XIENCE PRO 48 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: 10852864
• MDR Text Key: 216948560
• Report Number: 2024168-2020-09601
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): Y
• Reporter Country Code: IT
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2022
• Device Catalogue Number: 1017300-48
• Device Lot Number: 9032841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 78