MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE PRO 48 EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT SYSTEM

Catalog Number 1017250-48

Device Problems Break (1069); Physical Resistance (2578); Physical Property Issue (3008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 pro is currently not commercially available in the u.S.However, it is similar to a device sold in the u.S.

Event Description

It was reported that the procedure was to treat a long lesion located in the heavily calcified and narrow distal left anterior descending (lad) artery.Rotablation of the lesion was performed followed by predilatation with a 2.5 x 20 mm nc trek balloon catheter.The 2.5 x 48 mm xience pro 48 stent delivery system was advanced; however, a lot of resistance was felt due to the heavily calcified lesion.It was also stated that during advancement the proximal shaft completely deformed and broke; however, the stent delivery system was able to reach the lesion and the stent was able to be deployed successfully in the distal lad.Another non-abbott stent was deployed successfully overlapping the xience pro 48 treating the proximal part of the lad.No adverse patient effects were reported.There was a delay in the procedure reported; however, it was not clinically significant for the patient.No additional information was provided.

Manufacturer Narrative

Internal file number - (b)(4).Evaluation summary: the device was returned for analysis.The reported irregular appearance was able to be confirmed and the reported shaft break was noted to be a shaft kink and multiple hypotube bends.The reported physical resistance was unable to be replicated in a testing environment as it was based on operational circumstances.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that as the stent delivery system was advanced resistance was met with the heavily calcified anatomy resulting in the reported physical resistance.Manipulation of the device resulted in the reported irregular appearance and the noted shaft kink and bends.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.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE PRO 48 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: 6505133
• MDR Text Key: 73380919
• Report Number: 2024168-2017-03396
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2019
• Device Catalogue Number: 1017250-48
• Device Lot Number: 6062541
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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