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

Catalog Number 1011709-38

Device Problems Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: (b)(4).The device was returned for analysis.The distal balloon shoulder had a radial tear measuring 1mm in length.The reported difficulty to position was unable to be confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.Based on a visual, dimensional and functional inspection of the returned device, there is no indication of a product quality issue with respect to manufacture, design or labeling.Based on the information provided, the reported difficulties appear to be related to circumstances of the procedure and not a product quality issue with respect to manufacture, design or labeling.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history identified no other incidents from this lot.Based on the information reviewed, there is no evidence to indicate the presence a potential quality issue with respect to manufacture, design or labeling.It should be noted that the instructions for use states: the xience prime ll everolimus eluting coronary stent systems are indicated for improving coronary luminal diameter in the following: patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions.For restoring coronary flow in patients experiencing acute myocardial infarction who present within 12 hours of symptom onset.For the treatment of patients presenting with in-stent restenosis in coronary artery lesions; chronic total occluded coronary artery lesions and coronary artery bifurcation lesions.The xience prime ll everolimus eluting coronary stent systems are also indicated for improving peripheral luminal diameter in the following: for the treatment of severe claudication or critical limb ischemia (cli) due to infrapopliteal occlusive lesions.

Event Description

It was reported that the procedure was to treat a mildly calcified lesion in the proximal anterior tibial artery.The 3.0x38 mm xience prime stent delivery system (sds) was loaded onto the guide wire however resistance was met with the guide wire during advancement and the device failed to cross the target lesion.The xience prime sds was removed from the patient anatomy and the procedure was successfully completed with a new xience prime stent over the same guide wire.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.Returned device analysis revealed a radial tear in the balloon.

Manufacturer Narrative

(b)(4).

• 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: 5458679
• MDR Text Key: 39088398
• Report Number: 2024168-2016-01111
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2018
• Device Catalogue Number: 1011709-38
• Device Lot Number: 5091741
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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 Age: 89 YR
• Patient Weight: 72