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

Catalog Number 1076350-28

Device Problems Premature Activation (1484); Product Quality Problem (1506); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/28/2018

Event Type  malfunction  

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 relevant information.The xience prox device is currently not commercially available in the us; however, it is similar to a device sold in the us.

Event Description

It was reported that the procedure was to treat a 90% stenosed, ectatic, and moderately calcified de novo lesion in the distal right coronary artery.The lesion was pre-dilated with a 3.0x20mm trek balloon dilatation catheter.An attempt to advance a 3.5x28mm xience prox stent delivery system (sds) was made; however, the sds failed to cross the lesion.The sds was removed and once outside the anatomy it was noted that the stent struts were a little bit splayed [expanded] and seemed like the balloon stent was partially inflated; however, no pressure had been applied.A new 3.5x28mm xience prox sds was going to be used, but it was compared to the sds that failed to cross and it was noted that the 3.5x28mm xience prox sds had a bigger crimp profile.The procedure was successfully completed with the second 3.5x28mm xience prox sds and angiogram showed good results.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for evaluation and underwent a visual and dimensional inspection.The inflation issues were not confirmed.The reported failure to advance the device was unable to be replicated in a testing environment as it was based on operational circumstances.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 identified no similar incidents from this lot.A conclusive cause for the reported difficulties could not be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Manufacturer Narrative

(b)(4).The stent profile met specification, thus the larger stent crimp profile was not confirmed.It is likely that the failure to advance was due to the anatomy which was reported as 90% stenosed, ectatic, and moderately calcified.

• Brand Name: XIENCE PROX EVEROLIMUS ELUTING RX 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: 7987309
• MDR Text Key: 124568720
• Report Number: 2024168-2018-08057
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• Device Catalogue Number: 1076350-28
• Device Lot Number: 8032041
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/01/2018
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDE WIRE: RUNTHROUGH