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

Catalog Number 1011709-28

Device Problems Difficult or Delayed Positioning (1157); Difficult To Position (1467)

Patient Problems Angina (1710); Fatigue (1849); Ischemia (1942); Stenosis (2263)

Event Date 11/19/2012

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2012, the patient underwent a stenting procedure with placement of a 4.0 x 23 mm xience prime stent and a 3.0 x 28 mm xience prime stent in the left main coronary artery to circumflex artery.No post procedure intravascular ultrasound (ivus) was performed as the physician had difficulty advancing the ivus through the 3.0 x 28 mm xience prime.On (b)(6) 2012, the patient began experiencing non-serious increased fatigue.Patient was advised to take his betablocker at night rather than in the morning.On (b)(6) 2013, the patient experienced an episode of angina.The patient's medication dosages were changed.No additional intervention was provided and the chest pain continued.As the patient's angina continued, angiography was performed on (b)(6) 2014.Angiography noted instent restenosis in the stents implanted in the left main to the ostial circumflex.Additionally, the 3.0 x 28 mm xience prime was noted to be undersized, possibly related to the index procedure t-stenting technique.A 4.0 x 33 mm xience stent and a 3.0 x 12 mm xience stent were implanted in the cx artery back to the left main artery.Dilatation was performed in the left anterior descending (lad) artery, using an unspecified 3.0 mm balloon, followed by kissing balloon technique using an unspecified 3.0 balloon in the lad and a 4.0 balloon in the cx.There was poor flow distally (ischemia) and plain old balloon angioplasty (poba) was performed using an unspecified 2.5 nc balloon and then drug eluting balloon to the 2nd obtuse marginal with excellent final results.No additional information was provided.

Event Description

Subsequent to initial medwatch report filed on (b)(4) 2014, additional information was received indicating that the patient experienced continuing angina on (b)(6) 2014 and was re-hospitalized.The patient was discharged to home on (b)(6) 2014.No additional information was provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The device was not returned for evaluation; therefore a failure analysis of the complaint device could not be completed.A review of the lot history record revealed no non-conformances that would have contributed to the reported event.A query of the electronic complaint handling database indicated there had been no similar incidents reported for this lot.The reported patient effects of angina, ischemia, and restenosis are known observed and potential patient effects as listed in the xience prime everolimus eluting coronary stent system instructions for use.Based on the reviewed information, no product deficiency was identified.The 4.0x23mm xience prime referenced is being filed under a separate medwatch mfr number.

• Brand Name: XIENCE PRIME 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 462
• Manufacturer (Section G): CLONMEL, IRELAND REG# 9616693; abbott vascular; 26531 ynez road; temecula CA 92591 462
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 3638193
• MDR Text Key: 3988848
• Report Number: 2024168-2014-01016
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2013
• Device Catalogue Number: 1011709-28
• Device Lot Number: 1112241
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2011
• 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: XIENCE PRIME 3.5X23MM, 4.0X28MM; STENT: XIENCE PRIME 4.0X23MM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 47 YR
• Patient Weight: 87