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

Catalog Number	1550300-33
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported material rupture.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.The other xience sierra device referenced is being filed under a separate medwatch mfr number.
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the right coronary artery that was heavily calcified.After rotablation was performed, balloons were used for predilatation.The 3.0 x 33 mm xience sierra stent delivery system (sds) was advanced to the lesion without resistance, however, during the first inflation, the stent expanded but contrast was leaking and it was not possible to inflate the balloon.The xience sierra was removed from the anatomy and an attempt was made to inflate the balloon.The balloon expanded; however, there were multiple holes in the balloon.Then, the 2.25 x 15 mm xience sierra was advanced to the lesion but ruptured below rated burst pressure during the first inflation.Both sds balloons ruptured prematurely post-rotablation.A 3 x 32 mm non-abbott stent was deployed to complete the procedure.The devices were prepared according to the instructions for use and air aspiration was performed outside the anatomy prior to use without any issue.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Common Device Name: DRUG ELUTING CORONARY STENT SYSTEM
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• MDR Report Key: 8080059
• Report Number: 2024168-2018-08894
• Device Sequence Number: 16525723
• Product Code: NIQ
• UDI-Device Identifier: 08717648227295
• UDI-Public: 08717648227295
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P110019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/20/2019
• Device Catalogue Number: 1550300-33
• Device Lot Number: 8071641
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 97