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

Catalog Number 1550400-08

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant medical products: guide catheter: 8f al, guide wire: prowater, sheath: 8f.The stent remains in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The two 4.0x38mm xience sierra stents referenced are being filed under separate medwatch reports.

Event Description

It was reported that the procedure was performed to treat a moderately to severely stenosed lesion in the mid ostial left main coronary artery, and to treat a long, chronic totally occluded and calcified lesion in the right coronary artery (rca).A 4.0x08mm xience sierra stent was deployed in the left main artery at 12 atmospheres (atm) and post-dilated with a 4.0x08mm nc trek balloon at 20 atm; however, intravascular ultrasound (ivus) showed that the distal edge of the stent was mildly malapposed.As such, the stent was post-dilated with a 4.5x08mm nc trek balloon up to 20 atm.Follow-up ivus showed that the stent was well expanded and apposed throughout.A 3.0x18mm xience sierra stent was deployed in the proximal posterior descending artery (pda).A 4.0x38mm xience sierra stent was deployed at 14 atm without reported issue distal to the av groove rca.A second 4.0x38mm xience sierra was advanced and deployed at 14 atm without reported issue.Follow-up angiography revealed restoration of antegrade flow in the pda; however, some dye extravasation was noted outside the vessel of the mid av groove rca, though it was not free-flowing and there was no evidence of pericardial fluid.A 4.0x15mm non-abbott balloon was used to post-dilate the av groove.Follow-up angiography showed reasonable stent results; however, borderline extravasation was still noted in the mid rca.Two 4.0x19mm graftmaster covered stents were deployed to treat the perforation.The patient was given protamine medication and was transferred to the intensive care unit in stable condition.The patient was discharged on (b)(6) 2019.No additional information was provided.

Manufacturer Narrative

Device codes: 2993 labeled na.Internal file number - (b)(4).Correction: mfr site - reg#.Code 2682 was removed.The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.An investigation was not conducted because there were no specific reported device malfunctions or patient effects associated with this device.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Subsequent to the initially filed report, the following additional information was received: there were no issues with the deployment of the 4.0x8 xience sierra stent and post-dilatation was performed as per standard procedure.Neither 4.0x38mm xience sierra stent caused the perforation.The perforation was noted after the post-dilatation with the 4.0x15 non-abbott balloon dilatation catheter.The two graftmaster covered stents were confirmed to be used due to the size of the perforation.There were no issues noted with either graftmaster device, and the graftmaster devices did not cause or contribute to any complications or adverse events.No additional information was provided.

• Brand Name: XIENCE SIERRA 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
• MDR Report Key: 8652349
• MDR Text Key: 146469471
• Report Number: 2024168-2019-04192
• Device Sequence Number: 1
• Product Code: NIQ
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/20/2019
• Device Catalogue Number: 1550400-08
• Device Lot Number: 8051141
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SEE H10 FOR CONCOMITANT MEDICAL DEVICES.
• Patient Outcome(s): Required Intervention
• Patient Age: 91 YR
• Patient Weight: 63