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

Catalog Number 1500275-28

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Intimal Dissection (1333)

Event Date 05/08/2018

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: dilitation catheter: tazuna 2.5 x20, nc trek 2.75 x15, euphora (2.5x20, 3x30); guide wire: terumo runthrough ; guide catheter: ebu 4 7f.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 underwent a coronary procedure to treat a target lesion in the mid left anterior descending (lad) artery, with mild calcification.A non-abbott guide wire was advanced and pre-dilatation was performed using a 2.5 x 20 mm non-abbott dilatation catheter.A 2.75 x 28 mm xience sierra stent was implanted and a waist was noted in the mid stent.The stent delivery system (sds) was inflated several times to 18 atmospheres (atm).Post-dilatation was performed using a 2.75 x 15 mm nc trek dilatation catheter to optimize stent deployment.A proximal dissection was noted and a 3.0 x 18 mm non-abbott stent was implanted as treatment.Balloon inflations were performed to treat the dissection between the stents.A second 2.5 x 20 mm non-abbott dilatation catheter was inflated to treat the remaining waist in the xience sierra stent.A 3.0 x 30 mm non-abbott dilatation catheter was inflated to treat the dissection distal to the implanted xience sierra.A 2.5 x 19 mm non-abbott stent was implanted; however, an additional vessel area was not covered.A 2.5 x 18 mm non-abbott stent was implanted to fully treat the dissection.Several balloon inflations were performed with good outcome.No additional information was provided.

Manufacturer Narrative

(b)(4).The device was not returned for analysis.The lot history record review and similar incident query were not performed because the lot number was not reported and the product was not returned for analysis.The reported patient effect of intimal dissection is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.The investigation was unable to determine a conclusive cause for the reported difficulty to deploy; however, the patient effect of intimal dissection appears to be related to the operational context of the procedure.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• 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
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7566313
• MDR Text Key: 109982887
• Report Number: 2024168-2018-04109
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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,Followup
• Report Date: 06/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1500275-28
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 83 YR