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

Catalog Number 1550300-38

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

Patient Problems Perforation (2001); Pericardial Effusion (3271)

Event Date 07/24/2019

Event Type  Injury  

Manufacturer Narrative

Exemption number (b)(4).The stent remains in patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The two 3.5x19mm graftmaster stents are being filed under separate medwatch report numbers.

Event Description

It was reported that the patient presented with nstemi and a 3.0x38 mm xience sierra stent and a 3.5x38 mm xience sierra stent were placed in the saphenous vein graft (svg) to posterior descending coronary artery (pda).There was under dilated resistant disease noted in the 3.0x38 mm xience sierra stent; therefore, high pressure dilatation was performed with a 3.5 mm non-compliant balloon dilatation catheter (bdc), and a perforation was noted.Balloon tamponade was attempted and then three graftmaster covered stents were implanted.Three graftmaster devices were required as there was persistent leak of the perforation.No issues with deployment of the graftmaster devices were noted.There was marked improvement; however, there was a mild persistent contrast blush.Stat echocardiography showed a small effusion on the right ventricle.Periocardiocentesis was performed.The perforation was ultimately sealed by the use of the graftmaster devices and post dilatation.The patient is stable.No additional information was provided.

Manufacturer Narrative

Exemption number e2019001.There was no reported device malfunction and the product was not returned.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 perforation and pericardial effusion are listed in the xience sierra 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.The additional treatments appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: XIENCE SIERRA
• Type of Device: DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8903704
• MDR Text Key: 154714693
• Report Number: 2024168-2019-10923
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08717648227301
• UDI-Public: 08717648227301
• Combination Product (y/n): N
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/10/2019

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: 04/15/2020
• Device Catalogue Number: 1550300-38
• Device Lot Number: 9041041
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/25/2019
• Initial Date FDA Received: 08/16/2019
• Supplement Dates Manufacturer Received: 08/22/2019
• Supplement Dates FDA Received: 09/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 3.5 NC TREK; 3.5X38 MM XIENCE SIERRA
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Weight: 66