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

Catalog Number 1070350-48

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

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Perforation (2001); Ventricular Tachycardia (2132)

Event Date 12/15/2016

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: xience xpedition: 2.5 x 15, 3.0 x 33, 3.5 x 48 and 4.0 x 18 , graftmaster 3.5 x 19.The device was not returned for evaluation.The reported patient effects of death, hypotension, perforation, and ventricular tachycardia are listed in the xience xpedition everolimus eluting coronary stent system instructions for use as known patient effects of coronary stenting procedures.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.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.

Event Description

It was reported the procedure on (b)(6) 2016 was to treat a patient with acute coronary syndrome (acs).Two xience xpedition stents (2.5x15 mm, 3.0x33 mm) were implanted in the mid left anterior descending (lad) artery.After the procedure, the patient suffered from chest pain and cold sweating; therefore, intravascular ultrasound (ivus) was performed which confirmed that the xience xpedition stents were well deployed; however, the proximal right coronary artery (rca) was noted to be occluded without flow.There was faint collateral artery from the lad apex to the rca.Ventricular fibrillation occurred twice while angiogram was performed which was stabilized after intra-aortic balloon pump and a temporary pacemaker as well as closely monitoring in the icu.Post diagnosis revealed the mid rca to rca/posterior descending artery (pda) with stenosis and dissection spontaneously with timi 3.Ivus revealed a large rca vessel dissection from the mid to distal rca and hematoma.On (b)(6) 2016, three xience xpeditions (3.5x48 mm (x2), 4.0x18 mm) were implanted in the rca.Ivus revealed a perforation occurred at the mid rca where the 3.5x48 mm stent was implanted.A 3.5x19 mm graftmaster was implanted to seal the perforation.Bedside echocardiography revealed small amount of pericardial effusion so pericardiocentesis was performed.The lesion was checked by ivus and post-dilatation was performed.Blood pressure dropped, tachycardia and cardiac arrest occurred.The patient was given medication and cpr was performed.The patient subsequently died on (b)(6) /2016 with right ventricular dysfunction and failure.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: 6238704
• MDR Text Key: 64389655
• Report Number: 2024168-2017-00270
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648158346
• UDI-Public: (01)08717648158346(17)190829(10)6082241
• 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: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/29/2019
• Device Catalogue Number: 1070350-48
• Device Lot Number: 6082241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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): Death
• Patient Age: 63 YR