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

Catalog Number 1550225-38

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/22/2019

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 in the patient.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional xience sierra device is being filed under a separate medwatch report.

Event Description

It was reported that on (b)(6) 2019, a coronary percutaneous intervention was performed.The patient presented with mildly elevated troponin (0.039 ng/ml) and long or multiple coronary artery lesions.A 3.25x15mm and a 2.25x38mm xience sierra stent were implanted in the first right posterior lateral coronary artery.Regarding both stents, stent under expansion was noted.A non-compliant balloon was used for post-dilatation.The post-procedure end flow was timi grade 3 with 0% diameter stenosis.No additional information was provided regarding this issue.

Manufacturer Narrative

Internal file number: (b)(4).The device was not returned for analysis.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 investigation was unable to determine a conclusive cause for the reported difficulty to deploy (wall apposition); however, the subsequent treatment appears to be related to the circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

Subsequent to the initial report, the additional information was noted.The mildly elevated troponin of 0.039ng/ml was post-procedure, not pre-procedure as previously reported.This was not reported as an adverse event.

• 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: 8633107
• MDR Text Key: 145833263
• Report Number: 2024168-2019-04015
• 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: 06/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Catalogue Number: 1550225-38
• Device Lot Number: 8112841
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE CATHETER: 6FHEPARINXIENCE SIERRA STENT; GUIDE CATHETER: 6FHEPARINXIENCE SIERRA STENT
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72