MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE XPEDITION 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1070300-48

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Ischemia (1942); Stenosis (2263)

Event Date 11/14/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The stent remains implanted.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of ischemia and stenosis are listed in the xience xpedition, everolimus eluting coronary stent system (eecss), instructions for use, as known patient effects of coronary stenting procedures.The investigation determined a conclusive cause for the reported difficult to deploy could not be determined.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 the design, manufacture or labeling of the device.The xience xpedition 48 is currently not commercially available in the us; however, it is similar to a device sold in the us.The xience sierra stent is being under a separate medwatch report.

Event Description

It was reported that on (b)(6) 2018, the patient underwent a coronary procedure.A 3.5 x 18 mm xience sierra stent was implanted in the mid left anterior descending (lad) and a 3.0 x 48 mm xience xpedition in the proximal right coronary artery (rca).During the procedure, stent under-expansion was noted at both implanted stents and additional post dilatation was performed.On (b)(6) 2019, the patient was re-hospitalized.A stress echocardiogram was performed and noted ischemia.Restenosis was noted at the 3.0 x 48 mm xience xpedition in the proximal rca and stenosis was noted in the circumflex (cx) artery, a non-target lesion.A revascularization procedure was performed, with implantation of a 3.0 x 12 mm xience stent in the rca and a 3.0 x 28 mm xience stent in the cx.No additional information was provided.

• Brand Name: XIENCE XPEDITION 48 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: 8742152
• MDR Text Key: 149484433
• Report Number: 2024168-2019-05191
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,s
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2021
• Device Catalogue Number: 1070300-48
• Device Lot Number: 8092641
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Weight: 85