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

Catalog Number 1070250-48

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

Patient Problem Shock (2072)

Event Date 08/21/2018

Event Type  Death  

Manufacturer Narrative

(b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: stent: 3.5 x 48 mm xience xpedition; xience alpine (2.5x23, 2.5x23).The stent remains in the patient.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.

Event Description

It was reported that the patient had pre-existing acute myocardial infarction with triple vessel disease.The lesions to be treated were in the left main bifurcation at the left anterior descending (lad), left circumflex (lcx) ostium, and right coronary artery.Blood pressure lowered during rotablation in the lad lesion, which caused a no-reflow afterwards.The puncture site sheath felt loose which caused blood loss in the patient.An urgent blood transfusion was provided.Intra-aortic balloon pump was attempted, but the physician could not pass through the transfemoral.A peripheral arterial occlusive disease stent was implanted successfully.Additionally, three (3) drug-eluting stents (xience xpedition 2.5x48mm, 3.5x48mm and xience alpine 2.5x23mm) were implanted in the lad and (1) (2.5x23mm xience alpine) in the lcx using a v-stenting technique.The patient continued to experience hemorrhagic shock.The next day, the patient died of suspected hemorrhagic shock.An autopsy was not performed.No additional information was provided.

Manufacturer Narrative

(b)(4).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 death is listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effect 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.

• 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: 7859823
• MDR Text Key: 119669599
• Report Number: 2024168-2018-06991
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2021
• Device Catalogue Number: 1070250-48
• Device Lot Number: 8042441
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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: SEE H10 FOR CONCOMITANT MEDICAL DEVICES
• Patient Outcome(s): Death