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

Catalog Number 1011707-38

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Dislodged or Dislocated (2923)

Patient Problems Intimal Dissection (1333); Cardiac Arrest (1762); Death (1802); Occlusion (1984); Ventricular Fibrillation (2130); Ventricular Tachycardia (2132)

Event Date 06/29/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all additional relevant information.The xience prime (4.0x38mm, 3.5x33mm) and xience alpine (2.5x38mm) referenced are being filed under separate medwatch reports.

Event Description

It was reported that the procedure was to treat a 90% stenosed, non-tortuous, and moderately calcified de novo lesion in the mid left main artery (lm), proximal circumflex (lcx), and proximal left anterior descending artery (lad).Following pre-dilatation, a 4.0x38mm xience prime stent was deployed from the lm to the lad.A 2.5x38mm xience prime stent delivery system (sds) was being advanced to deploy in the mid to distal lad; however, part of the stent became stuck in the deployed 4.0x38mm xience prime stent.The 2.5x38mm xience prime sds was pulled back, but the stent dislodged in the lm.A snare device was used to retrieve the 2.5x38mm xience prime stent; however, the 4.0x38mm xience prime stent also came out of the artery.While pulling back the 2.5x38mm xience prime a dissection occurred and the vessel occluded.The patient condition declined and cpr was started immediately; however, the patient experienced ventricular tachycardia and ventricular fibrillation.A 2.5x38mm xience alpine stent was deployed in the mid to distal lad and a 3.5x33mm xience prime stent was deployed in the lm to lad.Stent foreshortening was observed post dilatation for the 2.5x38mm xience alpine.Angiography was performed and thrombus formation was noted in the 3.5x33 xience prime stent.An attempt to deploy a 2.5x38mm xience xpedition stent in the lm to lcx was made; however, the sds could not cross.The patient expired.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported stent dislodgement was confirmed.The reported failure to advance and the reported difficult to remove were unable to be replicated in a testing environment as they were based on operational circumstances.It should be noted that the xience prime instructions for use (ifu) states: when treating multiple lesions within the same vessel, stent the distal lesion prior to stenting the proximal lesion.Stenting in this order obviates the need to cross the proximal stent in placement of the distal stent, and reduces the chance of dislodging the proximal stent.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure and subsequent use error as it is likely that as the 2.5x38mm xience prime was being advanced to deploy in the mid to distal left anterior descending artery, part of the stent became stuck in the previously deployed 4.0x38mm xience prime stent resulting in the reported failure to advance.The 2.5x38mm xience prime stent delivery system was pulled back, but the stent dislodged in the left main artery; thus, resulting in the reported difficult to remove and the reported stent dislodgement.The reported difficulties possibly contributed to the reported patient effects; however, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.The reported patient effects of dissection, death, occlusion, ventricular fibrillation and ventricular tachycardia are listed in the xience prime ifu as known patient effects of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRIME LL 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): CLONMEL, IRELAND REG# 9616693; 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: 6737109
• MDR Text Key: 80856267
• Report Number: 2024168-2017-06173
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2020
• Device Catalogue Number: 1011707-38
• Device Lot Number: 7032041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/03/2017
• Initial Date FDA Received: 07/24/2017
• Supplement Dates Manufacturer Received: 09/18/2017
• Supplement Dates FDA Received: 09/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2017
• 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
• Patient Outcome(s): Death