MAUDE Adverse Event Report: AV-TEMECULA-CT ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM; BIORESORBABLE DRUG ELUTING SCAFFOLD

Catalog Number 1012462-23

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Intimal Dissection (1333); Angina (1710); Embolism (1829); Cardiac Enzyme Elevation (1838); Ischemia (1942); Thrombosis (2100); Stenosis (2263)

Event Date 08/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The segment was dilated and two xience prox stents (3.0 x 23, 3.5 x 23) were implanted.After that there was some kind of thrombus material leaving in the vessel.The patient received integrillin as perfusor.On (b)(6) a second angiogram was performed which noted a timi ii flow in the lad.Then they dilated the medial lad with a 4.0 x 15 mm non-abbott balloon catheter and then the flow was normal.On (b)(6) 2017 the patient came back to the hospital with chest pain and a positive troponin test.A coronary angiogram was performed and the bypass graft of the diagonalis side branch was found occluded.In the segment of the lad with the absorb gt1 scaffolds and xience prox stents the stenosis/thrombosis was not very high but the flow into the distal vessel was poor (timi 1-2).Optical coherence tomography (oct) was attempted, but the measurement was not very clear due to the guiding catheter.There was not enough contrast for a good oct measurement.Predilatation was performed within the absorb gt1 scaffolds using an unspecified balloon and a xience prox 2.75 x 33 mm stent was implanted.Then the flow into the distal vessel was better (timi 2-3).The procedure was ended at this stage.The final patient outcome was good.The ramus diagonalis was bypassed in (b)(6) 2017.No additional information was provided.Concomitant medical products: stent: unk xience, 3 xience prox; scaffold: absorb gt1 2.5 x 23.Therapy dates continued: (b)(6) 2017.The other absorb gt1 and 3 xience prox devices referenced in describe event or problem and concomitant medical products are being filed under separate medwatch reports.

Event Description

It was reported that the patient presented with a myocardial infarction (mi) on (b)(6) 2016.The proximal left anterior descending (lad) artery was dilated and an unspecified xience stent implanted for treatment.The patient's diagonalis branch was occluded prior to the procedure; however, the plan was to leave the stenosis for a second examination.The next day, treatment was attempted on the diagonalis branch to open it up; however, this was unsuccessful.During this examination the distal lad was treated.Vessel sizing was performed using intravascular ultrasound (ivus).Predilatation was performed with a 2.5 x 20 mm non-abbott balloon several times up to 14 bar and two absorb gt1 scaffolds (3.0 x 28, 2.5 x 23) were implanted.Post-dilatation was performed with a 3.0 x 20 mm non-abbott balloon catheter.After post-dilatation, a dissection was noted which was treated with a xience prox 3.0 x 12 mm stent.No imaging was performed to confirm the scaffolds were fully apposed to the vessel wall.Then the patient underwent bypass surgery on the diagonalis side branch.The patient was placed on dual anti-platelet therapy consisting of prasugrel.The patient came back to the hospital on (b)(6) 2016 for an elective diagonalis dilatation.During this examination the angiogram showed a subacute thrombosis of the distal lad segment where the absorb gt1 scaffolds and 3.0 x 12 xience prox were located.The unspecified xience implanted in the proximal lad was patent.

Manufacturer Narrative

(b)(4).There was no reported device malfunction and the product was not returned as the scaffold remains in the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of dissection, angina, ischemia, thrombosis and restenosis, as listed in the bioresorbable vascular scaffold (bvs) system, absorb, instructions for use are known adverse events associated with the use of a coronary scaffold in native coronary arteries.Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.

Event Description

Additional information received: this part is a 2.5x23mm absorb rx, not a 2.5x23mm absorb gt1 as initially reported.

Manufacturer Narrative

(b)(4).

• Brand Name: ABSORB BIORESORBABLE VASCULAR SCAFFOLD SYSTEM
• Type of Device: BIORESORBABLE DRUG ELUTING SCAFFOLD
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 6931677
• MDR Text Key: 89149867
• Report Number: 2024168-2017-08071
• Device Sequence Number: 1
• Product Code: PNY
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P150023
• 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,Followup
• Report Date: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2017
• Device Catalogue Number: 1012462-23
• Device Lot Number: 5071662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/06/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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 Outcome(s): Hospitalization; Required Intervention