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

Catalog Number 1500350-28

Device Problems Positioning Failure (1158); Difficult to Remove (1528); Material Rupture (1546); Physical Resistance (2578); Material Deformation (2976)

Patient Problem Intimal Dissection (1333)

Event Date 04/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Both the xience sierra stent and balloon were retrieved in the guiding catheter, and all the devices were removed as a single unit.A dissection occurred in the lad and was left untreated.Additionally, the target lesion will be treated in approximately 6 weeks.The patient was discharged the following day from the hospital.No additional information was provided.Guide wire: sion blue.The xience sierra is currently not commercially available in the u.S.; however, it is similar to a device sold in the u.S.The device was received.Investigation is not yet complete.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was to treat a de novo lesion that was non-tortuous and heavily calcified located in the mid left anterior descending artery (lad) that was 90% stenosed.Pre-dilatation was performed in the first diagonal with a non-abbott balloon catheter at 10 atmospheres.A 3.0 x 23 mm xience sierra stent delivery system (sds) was advanced to the target lesion and successfully implanted in the first diagonal.Then the 3.0 x 23 mm sierra balloon was re-used for pre-dilatation in the mid lad.A 3.5 x 28 mm xience sierra sds could not cross the heavily calcified lad, and therefore a 7f guide liner was used with a non-abbott 2.5 x 20 mm balloon catheter for additional pre-dilatation.The 2.5 x 20 mm non-abbott balloon catheter was inflated to 16 atmospheres, but the xience sierra still could not cross the lesion.A 3.0 x 12 mm non-abbott balloon catheter was then selected and inflated to 14 atmospheres.The 3.5 x 28 mm xience sierra stent was advanced to the target lesion and during the first inflation at 8 atmospheres, the balloon ruptured and the stent partially deployed.A second unspecified wire was positioned to pull back the partially deployed stent and the balloon in the guideliner, but failed and the proximal edge of the stent became deformed.It was not possible to remove the guideliner from the sds, and a decision was made to cut the guideliner out of the sds.A non-abbott guide wire and a 2.5 x 20m mm non-abbott balloon catheter were advanced to the distal end of the partially deployed stent.The non-abbott balloon catheter was pulled back with the xience sierra stent and balloon.

Manufacturer Narrative

(b)(4).Internal file number - (b)(4).(b)(4).Evaluation summary: the device was returned for analysis.The reported material rupture was not confirmed; however, a tear in the outer member was observed.The reported material deformation was confirmed.The reported failure to deploy and difficulty to remove from the guide liner could not be tested due to the condition the device was returned.The reported difficulty to remove from the anatomy and physical resistance was unable to be replicated in a testing environment as they were 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 other incidents from this lot.The investigation determined the reported physical resistance appears to be related to circumstances of the procedure furthermore, the reported partial deployment, difficulty removing and material deformation appear to be related to the circumstances of the procedure as the device only partial deployed due to the noted outer member tear and interacted with the anatomy and guide catheter extension during removal resulting in the material deformation.The reported dissection is related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: XIENCE SIERRA 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: 7472906
• MDR Text Key: 106898449
• Report Number: 2024168-2018-03153
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Catalogue Number: 1500350-28
• Device Lot Number: 8010641
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2018
• 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): Hospitalization; Required Intervention